The Capital Project Manager is responsible for the end‑to‑end delivery of capital projects within a GMP-regulated manufacturing environment, from project initiation through commissioning, qualification, and handover. This role requires hands-on construction management capability, strong cross‑functional leadership, and demonstrated experience delivering manufacturing, utilities, and infrastructure projects in compliance with GMP, quality, and regulatory requirements.

The Project Manager is accountable for scope, schedule, cost, quality, safety, and risk, and serves as the primary interface between Engineering, Construction, Quality, Validation, Operations, and external partners.

Capital Project Manager Responsibilities:

Project Leadership & Governance

• Lead capital projects in accordance with enterprise capital governance and phase‑gate requirements 
• Act as single point of accountability for project execution, decision-making, and escalation
• Align project objectives with business needs, operational readiness, and regulatory expectations
• Provide clear and proactive communication to senior leadership and stakeholders

Scope, Cost & Schedule Management

• Define and manage project scope, ensuring alignment with approved business requirements
• Develop, maintain, and control integrated cost and schedule baselines
• Lead change management, trend analysis, and forecast‑at‑completion reporting 
• Ensure timely identification and mitigation of project risks and constraints

Design & Engineering Oversight (GMP Environment)

• Oversee development and approval of URS, Basis of Design, specifications, and drawings
• Ensure GMP design principles are embedded (material/personnel flow, segregation, cleanability)
• Facilitate GMP and constructability design reviews with Quality and Operations
• Ensure documentation supports validation, regulatory inspection, and lifecycle management

Construction Management

• Lead construction planning and execution, including site logistics, sequencing, and safety
• Manage contractors, CM firms, and vendors to ensure efficient and compliant delivery
• Oversee daily/weekly construction progress, field change control, and issue resolution
• Enforce GMP construction controls: segregation, cleanliness, and controlled turnover

Commissioning, Qualification & Validation

• Ensure structured system turnover from construction to commissioning
• Coordinate commissioning activities to support qualification readiness
• Partner with Validation and Quality to support IQ/OQ/PQ execution
• Issue complete, audit‑ready turnover packages to Operations and Quality

Regulatory & Quality Compliance

• Ensure alignment with site change control and regulatory impact assessment requirements
• Support regulatory filings, inspections, and audits as required
• Maintain project documentation in a state of inspection readiness

Closeout & Operations Readiness

• Deliver complete project closeout, including financial, technical, and regulatory documentation
• Support training, SOP updates, asset capitalization, and maintenance handover
• Capture and communicate lessons learned to improve future project delivery

Project Initiation & Planning

• Approved Project Charter and Capital Authorization
• Stakeholder & Communication Plan
• GMP Impact Assessment and Change Control initiation
• Initial Cost Estimate and Level 1–2 Schedule

Design & Pre‑Construction

• User Requirements Specification (URS)
• Basis of Design (BOD)
• GMP Design Review Packages
• Class 3/2 Cost Estimates
• Integrated Master Schedule
• Procurement and long‑lead strategy 

Construction & Execution

• Construction Execution Plan and Site Logistics Plan
• Contractor contracts and bid evaluation documentation
• Weekly and monthly cost/schedule reports
• Change orders and field change documentation
• GMP construction compliance records

Commissioning, Qualification & Validation

• System Turnover Packages
• Commissioning Plans and Reports
• IQ/OQ/PQ support documentation
• Traceability between URS and qualification

Turnover & Closeout

• As‑Built Drawings
• Asset Handover and Operations Readiness Package
• Final Cost Report and Forecast Variance Analysis
• Lessons Learned Report
• In‑Service Date (ISD) approval documentation 

Requirements:

• Bachelor’s degree in Engineering, Construction Management, or related field
• Significant experience delivering capital projects in GMP manufacturing environments
• Strong construction execution and contractor management background
• Demonstrated knowledge of:
  • GMP facility design and construction practices
  • Commissioning and qualification processes
  • Capital cost control, forecasting, and scheduling
• Proven ability to lead cross‑functional teams in regulated environments

Key Competencies:

• Capital project delivery leadership
• GMP and regulatory awareness
• Construction execution and problem solving
• Cost, schedule, and risk management
• Clear executive‑level communication

We are seeking a CQV Engineer with hands-on experience supporting solution preparation systems within biopharmaceutical manufacturing environments. This role will focus on solution preparation, buffer preparation, and media preparation unit operations, supporting commissioning, qualification, and validation activities to ensure systems are designed, installed, tested, and qualified in compliance with cGMP and regulatory expectations.

The ideal candidate will have strong experience across the CQV lifecycle, including authoring validation documentation, supporting equipment startup and commissioning activities, coordinating vendor testing, and ensuring systems achieve operational readiness. Experience working within digital validation platforms such as Kneat is highly desirable.

This position requires an individual who can work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution.

Solution Preparation Principal CQV Engineer Responsibilities:

Commissioning, Qualification & Validation

• Support commissioning, qualification, and validation (CQV) activities for solution preparation systems used in biopharmaceutical manufacturing.

• Author, review, and execute CQV lifecycle documentation including:

  • Commissioning test protocols

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Validation summary reports

• Ensure validation documentation complies with cGMP regulations and internal quality procedures.

• Participate in system impact assessments, risk assessments, and validation planning activities.

Solution Preparation Process Support

• Provide technical support for solution preparation unit operations, including systems such as:

  • Buffer preparation systems

  • Media preparation systems

  • Solution preparation tanks and mixing systems

  • Single-use mixing systems

  • Transfer and hold systems

• Support equipment startup and operational readiness for solution preparation processes.

• Assist with troubleshooting and process verification during commissioning and qualification activities.

Vendor & Equipment Startup

• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment.

• Coordinate with equipment vendors and system integrators to ensure systems are installed and functioning according to design specifications.

• Participate in equipment startup, commissioning, and operational testing activities.

Cross-Functional Coordination

• Collaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.

• Assist with deviation investigations, change control processes, and documentation updates.

• Ensure CQV activities align with project schedules and operational readiness milestones.

Digital Validation Systems

• Utilize electronic validation platforms (e.g., Kneat) to develop, manage, and execute validation documentation.

• Maintain data integrity, traceability, and compliance within digital validation systems.

Requirements:

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or related technical field

• Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments

• Hands-on experience with solution preparation, buffer prep, or media prep systems

• Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports)

• Ability to work independently while coordinating with cross-functional teams

• Strong technical documentation and communication skills

• Experience using digital validation platforms such as Kneat

• Experience supporting FAT/SAT, commissioning, and equipment startup

• Familiarity with single-use systems and biologics manufacturing processes

• Experience working within biologics or cell culture manufacturing facilities

• Onsite job requirement in Apex, NC

We are seeking a CQV Engineer with hands-on experience supporting Clean-in-Place (CIP) systems within biopharmaceutical manufacturing environments. This role will focus on commissioning, qualification, and validation activities for CIP systems and related process equipment, ensuring systems are designed, installed, tested, and qualified in compliance with cGMP and regulatory expectations.

The ideal candidate will bring strong experience across the CQV lifecycle, including authoring validation documentation, supporting commissioning activities, coordinating vendor testing, and ensuring systems achieve operational readiness. Experience working within digital validation platforms such as Kneat is highly desirable.

This role requires someone who can work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution throughout the lifecycle of the system.

CIP (Clean-in-Place) CQV Engineer Responsibilities:

Commissioning, Qualification & Validation

• Support commissioning, qualification, and validation (CQV) activities for CIP systems and related process equipment.

• Author, review, and execute CQV lifecycle documentation including:

  • Commissioning protocols

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Validation summary reports

• Ensure validation documentation complies with cGMP requirements and regulatory expectations.

• Participate in system impact assessments, risk assessments, and validation planning activities.

CIP System Support

• Provide technical support for Clean-in-Place (CIP) systems and automated cleaning processes used in biopharmaceutical manufacturing.

• Support qualification of CIP skids, automated cleaning cycles, and associated process equipment.

• Verify cleaning cycle parameters including flow rates, temperatures, chemical concentrations, and cycle timing.

• Assist with troubleshooting and process verification during commissioning and qualification activities.

Vendor & Equipment Startup

• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new CIP equipment and systems.

• Coordinate with equipment vendors and system integrators to ensure systems are installed and functioning according to design specifications.

• Participate in equipment startup, commissioning, and operational testing activities.

Cross-Functional Collaboration

• Collaborate with engineering, automation, quality assurance, and manufacturing teams to ensure successful project execution.

• Assist with deviation investigations, change control processes, and documentation updates.

• Ensure CQV activities align with project schedules and operational readiness milestones.

Digital Validation Systems

• Utilize electronic validation platforms (e.g., Kneat) to develop, manage, and execute validation documentation.

• Ensure documentation integrity, traceability, and compliance within digital validation systems.

Requirements:

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or a related technical discipline

• Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments

• Hands-on experience with CIP systems and automated cleaning processes

• Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports)

• Ability to work independently while coordinating with cross-functional project teams

• Strong technical documentation and communication skills

• Experience using digital validation platforms such as Kneat

• Experience supporting FAT/SAT, commissioning, and equipment startup

• Familiarity with automated process systems and PLC-based equipment

• Experience in biologics or large-scale biopharmaceutical manufacturing environments

• Onsite job requirement in Apex, NC

We are seeking a CQV Engineer with hands-on experience in downstream bioprocessing systems to support commissioning, qualification, and validation activities within biopharmaceutical manufacturing environments. This role will focus on downstream unit operations and purification equipment, ensuring systems are designed, installed, tested, and qualified in accordance with cGMP and regulatory expectations.

The ideal candidate will have strong experience across the CQV lifecycle, including authoring validation documentation, supporting commissioning activities, coordinating vendor testing, and ensuring systems achieve operational readiness. Experience working with digital validation platforms such as Kneat is highly desirable.

This position requires an individual who can work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution.

Downstream Principal CQV Engineer Responsibilities:

Commissioning, Qualification & Validation

• Support commissioning, qualification, and validation (CQV) activities for downstream bioprocess equipment and systems.

• Author, review, and execute CQV lifecycle documentation including:

  • Commissioning test protocols

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Validation summary reports

• Ensure validation documentation complies with cGMP, regulatory standards, and internal quality procedures.

• Participate in system impact assessments, risk assessments, and validation planning activities.

Downstream Bioprocess Support

• Provide technical support for downstream purification unit operations, including systems such as:

  • Chromatography systems

  • Tangential Flow Filtration (TFF) / Ultrafiltration systems

  • Depth filtration systems

  • Viral filtration systems

  • Buffer preparation and hold systems

• Support equipment startup and operational readiness for downstream process systems.

• Assist with troubleshooting and process verification during commissioning and qualification activities.

Vendor & Startup Activities

• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new downstream process equipment.

• Coordinate with equipment vendors and system integrators to ensure proper installation and functionality.

• Participate in equipment startup, commissioning, and performance verification activities.

Cross-Functional Coordination

• Collaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.

• Support deviation investigations, change controls, and documentation updates as required.

• Ensure CQV activities are completed in accordance with project schedules and milestones.

Digital Validation Systems

• Utilize electronic validation platforms (e.g., Kneat) to author, manage, and execute validation documentation.

• Maintain documentation integrity and traceability within digital validation systems.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical discipline

• Experience supporting CQV activities in GMP-regulated pharmaceutical or biotechnology environments

• Hands-on experience with downstream bioprocess equipment and purification systems

• Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports)

• Ability to work independently while collaborating with cross-functional teams

• Strong documentation, organizational, and communication skills

• Experience with digital validation systems such as Kneat

• Experience supporting FAT/SAT, commissioning, and equipment startup

• Familiarity with risk-based validation approaches

• Experience in biologics manufacturing or monoclonal antibody production environments

• Onsite job requirement in Holly Springs, NC

We are seeking a CQV Engineer with hands-on experience in upstream bioprocessing systems to support commissioning, qualification, and validation activities for biopharmaceutical manufacturing operations. This role will focus on upstream unit operations and process equipment, ensuring systems are designed, installed, tested, and qualified in accordance with cGMP and regulatory expectations.

The ideal candidate will bring strong experience across the CQV lifecycle, including authoring validation documentation, coordinating commissioning activities, supporting vendor testing, and ensuring systems achieve operational readiness. Experience with digital validation platforms such as Kneat is highly desirable.

This position requires someone who can work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution.

Upstream Principal CQV Engineer Responsibilities:

Commissioning, Qualification & Validation

• Support commissioning, qualification, and validation (CQV) activities for upstream bioprocess equipment and systems.

• Author, review, and execute CQV lifecycle documentation including:

  • Commissioning test protocols

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Validation summary reports

• Ensure validation documentation aligns with cGMP requirements and regulatory expectations.

• Participate in system impact assessments, risk assessments, and validation planning activities.

Upstream Bioprocess Support

• Provide technical support for upstream bioprocess unit operations, including systems such as:

  • Bioreactors / fermenters

  • Media and buffer preparation systems

  • Cell culture support equipment

  • Filtration and associated upstream utilities

• Support equipment startup and operational readiness for upstream process systems.

• Collaborate with engineering and operations teams to resolve technical issues during commissioning and qualification.

Vendor & Startup Activities

• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment.

• Coordinate with equipment vendors and integrators to ensure proper system installation and functionality.

• Participate in equipment startup, troubleshooting, and performance verification.

Cross-Functional Coordination

• Work closely with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.

• Ensure commissioning and validation activities remain aligned with project timelines and milestones.

• Assist with deviation resolution, change control, and documentation updates as required.

Digital Validation Systems

• Utilize electronic validation platforms (e.g., Kneat) to develop and execute validation documentation.

• Ensure documentation integrity, traceability, and compliance within digital validation systems

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical field

• Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments

• Hands-on experience with upstream bioprocess equipment and systems

• Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ, protocols, reports)

• Ability to work cross-functionally with engineering, automation, vendors, and quality teams

• Strong communication, documentation, and organizational skills

• Experience with digital validation platforms such as Kneat

• Experience supporting FAT/SAT, commissioning, and equipment startup

• Familiarity with risk-based validation approaches

• Prior experience in biologics or cell culture manufacturing environments

• Onsite job requirement in Holly Springs, NC

Overview:

We are seeking a highly organized and detail-oriented Project Coordinator to support capital expenditure (CapEx) projects within a facilities and engineering environment. This individual will play a critical role in project controls, financial coordination, and procurement activities, ensuring projects are executed efficiently, compliantly, and in alignment with organizational standards.

The ideal candidate will bring strong experience in project coordination, financial tracking, and cross-functional collaboration, with the ability to manage multiple priorities in a fast-paced, regulated setting.

Project Coordinator Responsibilities:

• Support project controls processes, procedures, and systems for capital expenditure projects
• Maintain and communicate Facilities Notices (will be trained, no prior experience is required)
• Maintain and communicate Fire System Scheduler (will be trained, no prior experience is required)
• Process purchase requisitions and change orders
• Perform financial cross check on all requisitions for quality and CPC contracts processing standards
• Perform self-authoring of contracts for all requisitions and change orders
• Monitor purchase orders and identify potential issues and risks
• Prepare and present requisition status reports to project stakeholders.
• Identify opportunities to improve project controls processes and systems and make recommendations
• Ensure compliance with relevant regulations and industry standards
• Actively participate and support the contracts processing team
• Collaborate daily with the Legal, Procurement, and offshore database teams
• Comfortable in High Volume Job processing

Requirements:

• Bachelor’s degree in Business, Engineering, Construction Management, or related field preferred
• 2–5+ years of experience in project coordination, project controls, or capital projects support
• Experience with purchase requisitions, purchase orders, and financial tracking/reporting
• Strong proficiency in Microsoft Office (Excel, Word, PowerPoint); experience with ERP systems is a plus
• Familiarity with regulated environments (pharmaceutical, biotech, or manufacturing) is preferred
• Onsite job requirement in Novato, CA on a hybrid basis