Lead Validation Engineer Responsibilities:

• Lead second shift CQV execution activities across multiple systems and workstreams
• Coordinate daily execution priorities to recover schedule slippage and maintain timelines
• Interface with QA, Engineering, and Operations to resolve issues in real time
• Oversee execution of IQ/OQ protocols and operational verification activities
• Support and review: 
  • Drawing walkdowns
  • Equipment and component verification
  • Materials of Construction (MOC) and weld verification
• Provide oversight for temperature mapping and validation activities
• Support SIP/CIP and related cycle development activities as needed
• Ensure all documentation meets GMP/GDP and audit-ready standards
• Drive deviation identification, escalation, and resolution

Job Requirements:

• Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
• 8+ years of CQV/validation experience in pharma or biotech
• Strong hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF)
• Proven experience leading validation teams or shift-based execution efforts
• Strong GMP/GDP knowledge
• Experience with eVal (required), ValGenesis a plus
• Experience with temperature mapping (Ellab a plus)
• This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends

This role requires the ability to be on-site, full-time in Devens, MA.

Senior Validation Engineer Responsibilities:

• Execute IQ/OQ protocols and support operational verification activities
• Perform Drawing walkdowns (P&IDs, system verification)
• Perform Equipment/component verification
• Perform MOC and weld verification
• Support temperature mapping activities using data loggers and validation tools
• Assist with SIP/CIP execution and cycle development activities
• Identify and document deviations and support investigations
• Ensure accurate and complete documentation in compliance with GMP/GDP standards
• Work collaboratively with engineering, QA, and operations teams

Job Requirements:

• Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
• 3–8 years of CQV/validation experience
• Hands-on experience executing validation for process equipment
• Strong GMP/GDP fundamentals
• Experience with IQ/OQ execution and field verification activities
• Experience with eVal (required), ValGenesis a plus
• Exposure to temperature mapping (Ellab a plus)
• Experience with bioprocess equipment preferred (bioreactors, filtration, chromatography, UF)
• This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends

This role requires the ability to be on-site, full-time in Devens, MA.

Anduril Maritime is seeking a skilled and passionate Energy Systems Engineer to join our Enabling Technology team and make a direct impact on the performance and safety of our cutting-edge maritime products. In this role, you will be a key contributor, applying your technical expertise to design, develop, test, and certify the high-density energy systems that power our platforms.

You will work closely with the Enabling Technology team, platform leads and multi-disciplinary teams, focusing on the technical execution necessary to advance our energy solutions and ensure they meet the rigorous demands of harsh maritime environments. This is an opportunity for an engineer who thrives on solving complex technical challenges and contributing directly to mission-critical systems.

WHAT YOU'LL DO

Design & Development: Design, develop, and mature high-density energy storage systems through internal engineering projects, contributing directly to hardware and software solutions.

Technical Execution: Execute against sections of the energy technology roadmap, advancing current energy systems through capability development, validation, and optimization efforts.

Certification Support: Perform and support critical certification efforts for energy systems, including tasks related to UN38.3 and NAVSEA 9310.

Cross-Functional Collaboration: Collaborate effectively with multi-disciplinary internal teams and external vendors to integrate energy systems into Anduril Maritime products using agile development and CI/CD principles.

Requirements & Specifications: Contribute to the identification of energy demands, develop detailed technical specifications, and ensure our energy systems meet product requirements for endurance and safety.

Testing & Validation: Conduct rigorous testing, analysis, and validation of energy systems, documenting findings to support shipping and use certifications.

Technical Communication: Clearly communicate technical development status, findings, and issues to internal stakeholders, lead engineers, and potentially external partners.

Innovation & Research: Actively evaluate new energy technologies and industry trends, researching and proposing innovative solutions to enhance our product capabilities.

Proposal Contributions: Provide detailed technical inputs for proposals, including engineering execution plans, and contribute to customer deliverables and requests for information.

Trade Studies & Analysis: Perform mission and system-level trade studies and detailed analysis to inform design decisions, balancing risk, cost, and performance objectives.

Problem Solving: Actively participate in Root Cause Corrective Action (RCCA) activities for energy and power systems, ensuring lessons learned are integrated into design improvements and future requirements.

REQUIRED QUALIFICATIONS

• Bachelor of Science or higher degree in Chemistry, Chemical Engineering, Electrical Engineering, Mechanical Engineering, or Systems Engineering.
• At least 6+ years of years of hands-on experience working on power system design and development.
• Hands-on Development Experience: Demonstrated experience in designing, developing, testing, and supporting the delivery of cutting-edge, high-density energy storage systems for complex and harsh environments.
• Battery Safety: Experience contributing to the development and execution of battery safety plans.
• Strong Fundamentals: Deep technical fundamentals in energy storage systems, electronics design, and/or product development.
• High-Reliability Design: Experience designing high-reliability, mission-critical power systems.
• Eligible to obtain and maintain an active U.S. security clearance as a U.S. Citizen.

PREFERRED QUALIFICATIONS

• Requirements Execution: Proven ability to translate complex system requirements into executable technical tasks and successfully deliver against those demands.
• Technical Aptitude: Strong ability to execute technical development efforts, self-assess against key performance parameters, and work effectively across multiple engineering disciplines.
• Technical Communication: Excellent technical communication skills, with the ability to articulate critical technical findings and conclusions to various audiences.
• Experience supporting battery certification efforts, including UN38.3 certification as well as NAVSEA 9310.
• Experience with subsea electro-mechanical design.
• Experience contributing to product development in electro-mechanical systems, ideally energy systems.

In the first 3 months you'll

• Review and develop a working understanding of VEIR's cryogenic system designs, existing documentation, and outstanding technical questions.
• Complete engineering calculations or reports on at least two high-priority system problems, such as liquid nitrogen tank thermal management or manifold flow distribution.
• Build relationships with your cross-functional counterparts in mechanical, electrical, and systems engineering.
• Begin contributing to P&ID reviews, identifying gaps or inconsistencies in current design documentation. 

In the first 6 months you'll

• Own equipment specification and vendor qualification for one or more cryogenic subsystems, including selection of pumps, heat exchangers, tanks, or flow control components.
• Produce formal calculation reports or technical memos that support design decisions and are suitable for design review.
• Actively contribute to process safety reviews (HAZOP or equivalent) for relevant subsystems.
• Begin taking on design and analysis tasks within the 1.0 low voltage product program with limited oversight.

By the end of the first year, you will have

• Lead a cross-functional technical effort, coordinating internally and with external partners to resolve a complex system-level engineering question.
• Own the process engineering documentation library for assigned subsystems, including operating procedures, maintenance guidelines, and specification records.
• Be a recognized internal resource for cryogenic and thermal systems expertise, supporting design decisions across the 1.0 and HTS product lines.
• Demonstrate the ability to scope, structure, and independently drive engineering investigations from problem definition through to a documented, decision-ready output.

To be successful in this role

You bring:

• 6 to 8 years of experience in process or systems engineering, with a focus on thermofluids-intensive systems. Mechanical or chemical engineering degree required.
• Demonstrated proficiency in heat transfer, thermodynamics, and fluid systems design, including cryogenic or low-temperature applications.
• Hands-on experience reading, creating, and reviewing P&IDs and PFDs, with fluency in standard instrumentation and equipment symbols.
• Experience specifying and procuring major equipment items, including pumps, heat exchangers, cryogenic tanks, and associated controls.
• A track record of producing engineering documentation: calculation reports, equipment specifications, operating procedures, or design basis memos.
• Some exposure to process safety review methodologies (HAZOP, FMEA, or equivalent).
• Experience from oil and gas (specifically LNG), industrial gas, fusion energy, or space launch is directly relevant to the work here.

Nice to have:

• Direct cryogenic systems experience, specifically with liquid nitrogen, liquid hydrogen, or liquid oxygen handling.
• Field experience observing or participating in system construction, commissioning, or startup, and feeding those lessons back into design.
• Familiarity with the full project lifecycle: from concept and design through procurement, construction oversight, and commissioning.

You are:

• A systems thinker who can hold the full picture of a complex fluid system while knowing which details matter most.
• Comfortable working with ambiguity and incomplete information, structuring engineering problems before solving them.
• Skilled at communicating technical findings clearly in writing and in cross-functional settings.
• Energized by the pace and ownership that comes with an early-stage, high-impact deep tech environment.
• Collaborative and straightforward: you share what you know, ask when you don't, and hold yourself accountable to your commitments.

VEIR is committed to equal pay for equal work in its compensation practices. The base salary range for this position in the U.S. is $130,000 - $160,000 per year + equity + benefits. A candidate's salary is determined by various factors including, but not limited to, relevant work experience, skills, certifications, job level, supervisory status, and location.

POSITION OVERVIEW:
We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

WORK LOCATION:
Travel to client sites may be required up to 100% based on project phase and client needs.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be adjusted as needed.)

• Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
• Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
• Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
• Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.
• Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
• Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
• Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
• Support continuous improvement and process optimization initiatives.
• Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
• Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
• Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
• Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
• Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
• Develop and execute commissioning and qualification protocols.
• Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
• Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
• Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
• Participate in project planning, scheduling, risk assessments, and milestone tracking.
• Provide effective communication to stakeholders at all levels.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.

Experience

• Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
• Experience supporting commercial manufacturing operations in a regulated environment.
• Experience with commissioning, qualification, and engineering documentation.

Knowledge, Skills, and Abilities

• Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
• Strong documentation and technical writing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong communication, analytical, and problem-solving skills.
• Ability to work independently and collaboratively.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

About Formlabs:

Do you want to change how the world creates?

At Formlabs, we’re building the tools that make it possible for anyone to bring their ideas to life, from cutting-edge products to life-saving medical devices. Our 3D printing technology powers innovation at more than 50,000 industry leaders worldwide, including Apple, Google, Tesla, New Balance, and NASA. Together, we’re helping everyone design, prototype, and manufacture faster than ever before.

We’re a team of hands-on builders, engineers, and innovators reinventing how the world makes physical things. If you’re ready to shape the future of fabrication, come build it with us.

Your Impact: 

Formlabs is becoming a high-volume manufacturing powerhouse. We are rapidly growing our revenue and working on constantly overhauling our global supply chain.

To do this with an exceptional team, we cannot just work harder—we must fundamentally change how we work.

We are seeking a Head of Operational Excellence & Systems to serve as the "Automation and Efficiency Czar" for Global Operations. Reporting directly to the COO, you will own the mandate to eliminate non-value-add work across our seven operational disciplines (from our Ohio chemical plant to our APAC manufacturing sites). You will act as the central hub for process mapping, systems architecture, and AI implementation.

You will not just buy software; you will map broken processes, fix them, and then deploy the automation and AI tools necessary to give our operational leaders their time back.

What You’ll Do:

• Process Triage & Re-engineering: Audit workflows across Manufacturing, Fulfillment, Global Sourcing, and Compliance. Identify where manual handoffs are causing bottlenecks and fix the root process before applying technology.
• AI & Automation Strategy: Own the evaluation, procurement, and deployment of AI tools and automation software across Operations. Prevent "tool fatigue" by ensuring cohesive, integrated systems rather than disjointed, siloed applications.
• Cross-Functional Systems Architecture: Bridge the gaps between our departments. Connect the dots between demand planning data, sourcing, and our MES (Manufacturing Execution System) to create seamless, automated information flows.
• Change Management: Act as an internal consultant and coach. Work directly with functional leaders to identify "quick wins" (High Impact, Low Effort) that immediately relieve team work burden, building trust to tackle larger system overhauls quickly after.

About You:

• Deep Systems Thinking: You have 5+ years of experience in Operational Excellence, Systems Engineering, or Technical Product Management within a hardware, manufacturing, or complex physical supply chain environment.
• Technical Chops: You are highly fluent in modern ERPs, MES, and PLM systems, and you have a strong, practical grasp of how to deploy modern AI tools, RPA (Robotic Process Automation), and workflow automation.
• High EQ & Lateral Influence: You know how to drive change in a flat organization. You can comfortably partner with a Plant Manager in Ohio in the morning and a Lead Hardware Engineer in China in the evening, speaking their respective languages.
• Bias for Action: You are a builder, not just a consultant. You are not afraid to get into the weeds of a messy Google Sheet process to figure out how to automate it.
• Hands-On Automation Development: You have practical experience building internal tools and automations using languages such as Python and SQL, integrating systems via APIs, and leveraging modern workflow/RPA platforms. You are comfortable standing up dashboards and data visualizations (e.g., Looker Studio or similar BI tools) to operationalize solutions and drive decision-making.

Our Benefits & Perks:

• Robust equity program to build future wealth through RSUs
• Comprehensive healthcare coverage (Medical, Dental, Vision)
• 401K matching and access to financial advisors
• Generous paid Parental Leave (up to 16 weeks)
• Tenure-based paid Sabbatical Leave (up to 6 weeks)
• Flexible Out of Office Plan – Take time when you need it
• Ample on-site parking & pre-tax commuter benefits
• Healthy on-site lunches, snacks, beverages, & treats
• Regular sponsored professional development opportunities
• Many opt-in culture events across our diverse community
• And of course… unlimited 3D prints

We are an equal opportunity employer and value diversity at our company.  We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.  

Even if you don't check every box, but see yourself contributing, please apply. Help us build an inclusive community that will change the face of 3D printing.

About Formlabs:

Do you want to change how the world creates?

At Formlabs, we’re building the tools that make it possible for anyone to bring their ideas to life, from cutting-edge products to life-saving medical devices. Our 3D printing technology powers innovation at more than 50,000 industry leaders worldwide, including Apple, Google, Tesla, New Balance, and NASA. Together, we’re helping everyone design, prototype, and manufacture faster than ever before.

We’re a team of hands-on builders, engineers, and innovators reinventing how the world makes physical things. If you’re ready to shape the future of fabrication, come build it with us.

Your Impact: 

Materials development presents one of the greatest opportunities to innovate in 3D printing, unlocking new applications in different industries such as engineering, consumer, manufacturing, automotive and healthcare. Our materials science team works closely with product management, hardware and software teams to develop new materials that push the boundaries of what can be done with 3D printing.

If you are a scientist or engineer with experience in polymer development who’s excited to break new ground in an industry that’s moving at lightning speed, we want you as a Materials Scientist - Photopolymer Development!

What You’ll Do:

• Design and optimize complex photopolymer formulations to push the boundaries of additive manufacturing.
• Lead the end-to-end transition of new materials from lab scale concept to commercial launch, supporting technology transfer and scale-up.
• Establish structure-process-property relationships through rigorous experimentation and analytical characterization to meet demanding product specifications.
• Learn about the 3D printing process and underlying hardware, and use that knowledge to inform formulation decisions and provide input to future hardware decisions.
• Collaborate cross-functionally with product management, hardware, and software teams to develop products that meet customer needs and work seamlessly on the Form 4 platform.

About You:

• BS, MS, or PhD in polymer science, chemical engineering, chemistry, materials science or a related field.
• Results-oriented and motivated by delivering products in a fast-paced R&D environment.
• Experience developing thermoset materials including epoxies, urethanes, or acrylates.
• Enjoys working hands-on in the lab conducting experiments and analyzing large data sets to drive decision making.
• Able to work autonomously and push projects forward with a high level of independence. 
• Track record of success including publication, IP generation, or product commercialization.
• Practices good documentation and can organize complex data, create SOPs, and write clear, detailed internal reports.

Bonus Skills:

• Familiarity with additive manufacturing technologies
• Programming and digital analysis (Python, JMP, MATLAB, Minitab etc)
• Experience with high performance polymers, composites, or elastomers

Our Perks:

• Robust equity program to build future wealth through RSUs
• Comprehensive healthcare coverage (Medical, Dental, Vision)
• 401K matching and access to financial advisors
• Generous paid Parental Leave (up to 16 weeks)
• Tenure-based paid Sabbatical Leave (up to 6 weeks)
• Flexible Out of Office Plan – Take time when you need it
• Ample on-site parking & pre-tax commuter benefits
• Healthy on-site lunches, snacks, beverages, & treats
• Regular sponsored professional development opportunities
• Many opt-in culture events across our diverse community
• And of course… unlimited 3D prints

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Even if you don't check every box, but see yourself contributing, please apply. Help us build an inclusive community that will change the face of 3D printing.

About Formlabs:

Do you want to change how the world creates?

At Formlabs, we’re building the tools that make it possible for anyone to bring their ideas to life, from cutting-edge products to life-saving medical devices. Our 3D printing technology powers innovation at more than 50,000 industry leaders worldwide, including Apple, Google, Tesla, New Balance, and NASA. Together, we’re helping everyone design, prototype, and manufacture faster than ever before.

We’re a team of hands-on builders, engineers, and innovators reinventing how the world makes physical things. If you’re ready to shape the future of fabrication, come build it with us.

Your Impact: 

Materials development presents one of the greatest opportunities to innovate in 3D printing, unlocking new applications in different industries such as engineering, consumer, manufacturing, automotive and healthcare. Our materials science team works closely with product management, hardware and software teams to develop new materials that push the boundaries of what can be done with 3D printing.

If you are a scientist or engineer with experience in polymer development who’s excited to break new ground in an industry that’s moving at lightning speed, we want you as a Materials Scientist - Photopolymer Development!

What You’ll Do:

• Design and optimize complex photopolymer formulations to push the boundaries of additive manufacturing.
• Lead the end-to-end transition of new materials from lab scale concept to commercial launch, supporting technology transfer and scale-up.
• Establish structure-process-property relationships through rigorous experimentation and analytical characterization to meet demanding product specifications.
• Learn about the 3D printing process and underlying hardware, and use that knowledge to inform formulation decisions and provide input to future hardware decisions.
• Collaborate cross-functionally with product management, hardware, and software teams to develop products that meet customer needs and work seamlessly on the Form 4 platform.

About You:

• BS, MS, or PhD in polymer science, chemical engineering, chemistry, materials science or a related field.
• Results-oriented and motivated by delivering products in a fast-paced R&D environment.
• Experience developing thermoset materials including epoxies, urethanes, or acrylates.
• Enjoys working hands-on in the lab conducting experiments and analyzing large data sets to drive decision making.
• Able to work autonomously and push projects forward with a high level of independence. 
• Track record of success including publication, IP generation, or product commercialization.
• Practices good documentation and can organize complex data, create SOPs, and write clear, detailed internal reports.

Bonus Skills:

• Familiarity with additive manufacturing technologies
• Programming and digital analysis (Python, JMP, MATLAB, Minitab etc)
• Experience with high performance polymers, composites, or elastomers

Our Perks:

• Robust equity program to build future wealth through RSUs
• Comprehensive healthcare coverage (Medical, Dental, Vision)
• 401K matching and access to financial advisors
• Generous paid Parental Leave (up to 16 weeks)
• Tenure-based paid Sabbatical Leave (up to 6 weeks)
• Flexible Out of Office Plan – Take time when you need it
• Ample on-site parking & pre-tax commuter benefits
• Healthy on-site lunches, snacks, beverages, & treats
• Regular sponsored professional development opportunities
• Many opt-in culture events across our diverse community
• And of course… unlimited 3D prints

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Even if you don't check every box, but see yourself contributing, please apply. Help us build an inclusive community that will change the face of 3D printing.

Position Summary

We are seeking a Lead Scientist to drive the evolution of Ginkgo’s automated antibody production and developability platforms. This role is pivotal in bridging complex antibody engineering, specifically bi- and multi-specific formats, with Ginkgo’s RAC (Reconfigurable Automation Cart) systems. The ideal candidate is a technical expert in antibody transfection, purification, and characterization who thrives on translating manual workflows into robust, automated pipelines.

Key Responsibilities

• Lead method development and execution of antibody production and characterization on Ginkgo’s autonomous robotic labs using the RAC (reconfigurable automation cell) systems.
• Optimize high-throughput transfection and purification protocols for complex modalities, including bi-specifics and multi-specifics, at various scales (96 wp, 24 wp, 6 wp), ensuring high purity and correct assembly.
• Execute and automate standard developability suites (thermal stability, aggregation, polyreactivity, etc), binding assay (BLI, SPR) and functional assays (cell-based) to support rapid "Design-Build-Test" cycles.
• Serve as the project lead for customer projects focused on antibody production and developability characterization.
• Mentor junior scientists and contribute to scientific strategy and innovation.
• Author technical reports, SOPs, and present findings to internal leadership and external customers

Required Qualifications

• Ph.D. in Chemical Engineering, Bioengineering, Molecular Biology, or a related field with 2+ years of industry/academic experience in antibody production and characterization (or M.S. with 6+ years of industry/academic experience).
• Direct experience with the production and purification of complex antibody formats (e.g., bi-specifics, VHH-Fcs). Experience with Protein A/G/L, IEX, and SEC, specifically in a high-throughput or automated context.
• Demonstrated proficiency in antibody binding (SPR, BLI) and developability (DSF, DLS, SEC, HIC, AC-SINS, Polyreactivity, etc.) assays
• Demonstrated proficiency in using automated liquid handlers such as the Lynx, Bravo, TECAN, Hamilton

Preferred Qualifications

• Prior experience onboarding assays onto robotic platforms (e.g., translating a manual SEC-MALS or ELISA to a liquid handler).
• Experience with mass spectrometry (LC-MS) for confirming chain pairing in multi-specific formats.
• Familiarity with Python or scheduling software for automation.

Total compensation for this role is market driven, with a starting salary of $100k+, as well as company stock awards.  Base pay is ultimately determined based on a candidate's skills, expertise, and experience.  We also offer a comprehensive benefits package including medical, dental & vision coverage, health spending accounts, voluntary benefits, leave of absence policies, Employee Assistance Program, 401(k) program with employer contribution, 8 paid holidays in addition to a full-week winter shutdown and unlimited Paid Time Off policy.

Ginkgo has implemented a return to office policy effective October 1, 2025 with required in-office days 3x per week on Tuesday, Wednesday, Thursday.  Some teams may require to be onsite 4-5 days per week and this will be discussed as part of the interview process.  This policy applies to all employees who live within 50 miles of Ginkgo’s offices in Boston, MA, Emeryville, CA and West Sacramento, CA.

We're looking for a Senior Process Development Engineer to join our team. You will work onsite at our Devens, MA office, reporting into the Manager of Process Development Engineering. You will lead the implementation of assembly and lamination processes to promote new product introduction. You will work with the design, integration, and manufacturing teams to maintain current manufacturing processes.

Primary Responsibilities

• Design processes that can withstand variations in input parameters such as raw material and equipment settings, while maintaining output quality

• Plan verification to demonstrate initial feasibility and manufacturing capability

• Resolve process-related issues, conduct root cause analysis, and implement corrective actions

• Perform hands-on experimentation and diagnostic efforts to understand and resolve problems in new process implementation and ongoing manufacturing processes

• Create detailed process flow diagrams, Standard Operating Procedures (SOPs), Work Instructions (WIs) and other documentation to ensure consistency and quality

• Establish proper Statistical Process Control (SPC) schemes for new processes

• Lead continuous improvement projects and identify new opportunities for process optimization

• Present concise reports advising the readiness of manufacturing processes to a diverse set of program partners

Qualifications

• Bachelor's degree in Materials Science, Polymers, Chemical Engineering or related field with hands-on laboratory or manufacturing experience

• 8+ years experience with lamination of thin film layers

• Experience with large size lamination tools such as hydraulic presses, bladder presses, and R2R nip rollers

• Experience with tool procurement from start to finish (ERS, FAT, SAT process and tool install and commissioning efforts)

• Startup environment experience

• Experience with electrolyzers, fuel cells, or similar electrochemical systems

#LI-Onsite

Compensation and Benefits | P4