• Work is performed in office, laboratory, and manufacturing environments.

• Regular interaction with production floor operations for quality reviews and troubleshooting.

• Use of precision measurement and inspection equipment as needed.

• Potential exposure to manufacturing noise, equipment, and regulated materials.

• PPE required when performing inspections or working in controlled environments.

• Standard business schedule with occasional overtime or travel to supplier sites or customer locations.

• Performs engineering analyses by collecting data, reviewing operational trends, and preparing technical observations to support evaluations of equipment performance and reliability.

• Supports professional engineering activities related to installation, modification, and qualification of manufacturing equipment, ensuring alignment with established engineering standards and production requirements.

• Executes advanced maintenance, repair, and technical adjustments on complex manufacturing equipment by applying extensive procedural knowledge and hands-on expertise.

• Contributes to equipment troubleshooting efforts by applying engineering principles to initial assessments and collaborating on the development of corrective actions and process improvements.

• Develops and maintains engineering documentation, including specifications, change records, technical instructions, and performance logs, ensuring accuracy and compliance with engineering controls.

• Collaborates with engineers, maintenance personnel, and operations teams on continuous improvement initiatives that enhance equipment capability, efficiency, and reliability.

• Participates in equipment testing, calibration, and verification activities to support engineering evaluations and adherence to technical standards.

• Applies professional judgment within defined engineering procedures while upholding safety, quality, and regulatory requirements in all aspects of equipment engineering support.

• These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion. 

• Bachelor’s degree in mechanical engineering, electrical engineering, manufacturing engineering, or a related technical discipline.

• 0–2 years of relevant engineering experience, preferably in a manufacturing or production environment.

• Basic understanding of mechanical, electrical, pneumatic, and control systems.

• Familiarity with CAD tools, technical drawings, and engineering documentation.

• Knowledge of root cause analysis methods and problem-solving techniques is preferred.

• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include: 

• GMP quality management systems (e.g. ISO 13485)

• Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)

• Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)

• Analytical mindset with strong problem-solving and technical reasoning abilities.

• Ability to learn and apply engineering concepts to practical manufacturing challenges.

• Effective communication and collaboration skills across technical and operations teams.

• Attention to detail and accuracy in documentation and data analysis.

• Commitment to safety, quality, and continuous improvement principles.

• Works primarily in a manufacturing and engineering environment with regular exposure to production areas, equipment, and occasional noise.

• May require standing, walking, and occasional lifting during equipment inspections or installations.

• Use of personal protective equipment (PPE) is required when working on or near production equipment.

• Work may occasionally extend beyond regular hours to support maintenance or installation schedules.

• Provide advanced support for activities across business areas or groups

• Review all documentation related to the work area and collaborates with stakeholders to identify areas for process improvement

• Contribute towards best practice methods and procedures on new assignments

• Work on assignments requiring considerable judgment and initiative 

• Understand implications of work and makes recommendations for solutions

• Gather and analyzes information to identify and solve problems that arise with minimal guidance 

• Use knowledge of team interdependencies to impact achievement of objectives 

• Develop specialized skills through job-related training and considerable on-the-job experience 

• Apply in-depth skills and understanding in multiple processes and procedures to carry out assignments or developed skills in a single area

• Impact own team and other teams whose work activities are closely related

• Suggest improvements to existing processes and solutions to improve the efficiency of the team

• Network with peers and internal partners and may interact across functional area

• Informal team leader, providing work direction to others

• These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.

• Conducts professional engineering analyses to assess equipment performance, identify reliability concerns, and develop data-driven recommendations for improvement.

• Supports the installation, modification, and qualification of laboratory manufacturing equipment by applying engineering principles and collaborating with technicians, engineers, and operations teams.

• Executes advanced maintenance, repair, and technical adjustments on complex manufacturing equipment by applying extensive procedural knowledge and hands-on expertise

• Applies structured problem-solving methods to troubleshoot equipment issues, develop corrective actions, and implement improvements that strengthen equipment reliability.

• Develops, updates, and maintains engineering documentation, including technical specifications, process instructions, test results, and change records, in accordance with engineering controls.

• Collaborates with cross-functional partners on continuous improvement initiatives, contributing engineering insights that enhance equipment capability, throughput, and performance.

• Supports preventive and predictive maintenance programs by evaluating equipment behavior, reviewing failure data, and recommending engineering-driven reliability enhancements.

• Performs engineering-level testing, calibration, and verification activities to ensure equipment accuracy and compliance with quality and safety standards.

• Exercises professional judgment within established engineering practices to ensure safe, compliant, and efficient operation of manufacturing equipment.

• These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion. 

• Bachelor’s degree in mechanical engineering, electrical engineering, manufacturing engineering, or related discipline.

• 2 + years of relevant experience in equipment engineering, manufacturing, or maintenance engineering, or a master’s degree with 0–2 years of experience.

• Demonstrated knowledge of automated manufacturing systems, control systems, and process instrumentation.

• Proficiency in reading and interpreting mechanical and electrical drawings and schematics.

• Familiarity with root cause analysis and failure mode and effects analysis (FMEA) tools.

• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include: 

• GMP quality management systems (e.g. ISO 13485)

• Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)

• Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)

 

• Strong problem-solving skills with the ability to diagnose complex equipment and process issues.

• Analytical and data-driven approach to process improvement and decision-making.

• Effective collaboration and communication skills across technical and operational teams.

• Ability to manage multiple assignments and adapt to changing priorities in a fast-paced environment.

• Commitment to quality, safety, and operational excellence.

 

• Works in a manufacturing and engineering environment with frequent exposure to production equipment, machinery, and moderate noise.

• May require hands-on support in production areas, including standing, bending, or lifting equipment components.

• Use of personal protective equipment (PPE) is required per safety and compliance standards.

• May occasionally require overtime or off-shift support to address critical maintenance or project activities.

• Define and execute the strategic direction for the customer service organization, ensuring alignment with company goals.

• Lead and oversee multiple customer service teams, regions, or business units, managing managers and senior leaders.

• Develop and monitor key performance indicators (KPIs), ensuring the organization meets or exceeds customer satisfaction, quality, and operational goals.

• Partner with executive leadership across functions (e.g., Sales, Operations, Finance, IT, Marketing) to create seamless customer experiences and resolve systemic issues.

• Oversee departmental budgets, staffing, and resource planning to ensure efficient and cost-effective operations.

• Drive innovation by implementing new tools, technologies, and service models that enhance customer support and scale with business growth.

• Serve as the voice of the customer in strategic discussions, influencing company-wide initiatives and priorities.

• Ensure compliance with legal, regulatory, and quality standards across all service operations.

• Develop and mentor senior leaders, building a strong pipeline of leadership talent within the customer service function.

• Represent the company at customer meetings, industry events, and with key stakeholders to reinforce the organization’s commitment to service excellence.

• These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.
   

Adaptability and Growth Expectation

As our organization continues to evolve and grow, this role may require flexibility in responsibilities and duties.  Employees should expect that their role may expand, shift, or be modified to meet changing business needs, strategic priorities, and organizational objectives.
  

 This may include:

• Taking on additional responsibilities.

• Participating in cross functional projects and initiatives. 

• Adapting to new technologies, processes, or methodologies.

• Supporting other departments or teams during periods of high demand.

• Contributing to special projects or temporary assignments as needed.

• Bachelor’s degree in Business, Communications, or a related field required; Master’s degree strongly preferred.

• 12+ years of relevant customer service experience, including 5+ years in leadership roles managing large, complex organizations OR candidates with 7+ years of related experience and must have GRAIL experience eligible for consideration.

• Exceptional leadership and organizational management skills, with the ability to lead leaders and drive alignment across multiple functions.

• Strategic thinker with proven ability to design and implement customer service strategies that deliver measurable results.

• Ability to travel 20% as required.

• 15+ years of relevant customer service (call center experience), including 8+ years in leadership roles managing large, complex organizations.

• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:  

  • Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)

  • Protected health information (e.g. HIPAA, GDPR)

  • Strong financial and business acumen, with experience managing large budgets and driving operational efficiency.

  • Expertise in customer service operations, including contact center management, customer experience strategy, and process optimization.

  • Excellent communication and influencing skills to engage effectively with executives, employees, and external stakeholders.

  • Proven track record of leading large-scale transformation, change management, and technology adoption initiatives.

  • Strong commitment to customer advocacy and delivering outstanding customer experiences.

  Working Conditions 

  • Office-based environment with flexibility for hybrid or remote work depending on business needs.

  • Extended work hours may be required to address critical issues, strategic initiatives, or global operations.

  • Frequent interaction with executive leadership, senior stakeholders, and external partners.

  • Regular travel may be required to company sites, customer locations, and industry events.

• Hours and days may vary depending on operational needs.

• Standing or sitting for long periods of time may be necessary.

• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation.

• Some lifting (up to 25 pounds) may be necessary

• Ability to travel 20% as required

Quality Systems Training Program Execution

• Support the execution and continuous improvement of the Quality Systems Training Program in alignment with GRAIL’s QMS, regulatory requirements, and internal compliance expectations.

• Partner with Quality leadership and cross-functional stakeholders to implement quality training strategies that support business initiatives, role readiness, and organizational effectiveness.

• Ensure training processes are administered in a compliant, consistent, and inspection-ready manner across applicable functions.

• Support standardization of training practices, governance, and documentation to promote effectiveness, scalability, and consistency across the organization.

 

Veeva Vault LMS Administration and Configuration

• Administer and maintain training objects within Veeva Vault LMS, including learner roles, curricula, training assignments, notifications, dashboards, reports, and related system configuration elements.

• Support ongoing LMS configuration and optimization to ensure role-based training assignments, curricula structures, training-dependent access, and reporting capabilities remain accurate and aligned to business needs.

• Partner with IT and applicable business owners to support training-related onboarding and access workflows, as required.

• Partner with Document Control, document authors, training leads, functional leads, and process owners to translate document changes and procedural updates into appropriate training assignments and curricula updates.

• Support administration of training forms, records, and associated documentation in accordance with Good Documentation Practices (GDP) and document control requirements.

• Help ensure training metadata, assignment logic, and LMS structures are configured appropriately to support compliant training issuance and completion tracking.

• Contribute to special projects and broader program enhancements related to quality systems training, LMS process improvements, lab training functionality, and inspection readiness initiatives.

• Support training effectiveness activities by evaluating metrics, learner feedback, competency outcomes, deviations, CAPAs, and audit observations related to training systems and processes.

• May participate in internal audits, external inspections, and other readiness activities by preparing training-related documentation, reports, evidence, and responses to requests.

• Support Veeva LMS administration and coordination of clinical lab training and on-the-job training (OJT) processes in collaboration with laboratory leadership, functional leads, and qualified trainers.

• Partner with clinical lab stakeholders to help ensure training documentation, training records, and competency-related records are maintained and organized in accordance with applicable procedures and retention requirements.

• Bachelor’s degree in Life Sciences, Education, Quality, Regulatory, Clinical Laboratory Science, or a related discipline.

• Experience working in a regulated environment governed by one or more of the following: GxP, ISO 13485, ISO 15189, 21 CFR Part 820, 21 CFR Part 493 (CLIA), CAP, and 21 CFR Part 11.

• Progressive experience in training, quality systems, learning management systems, or regulated operations within the life sciences, medical device, biotech, diagnostics, or clinical laboratory environment.

• Experience administering or supporting a Learning Management System (LMS) in a regulated environment.

• Experience supporting or managing training processes tied to quality systems, controlled documents, and role-based training requirements.

• Strong analytical, organizational, and project management skills, with the ability to manage multiple priorities and stakeholders simultaneously.

• Strong written and verbal communication skills, including the ability to facilitate training, communicate requirements clearly, and partner effectively across functions.

• Inspection readiness mindset and experience supporting training-related compliance activities.

• Experience with Veeva Vault Training / Veeva Vault QMS, including curricula, learner roles, training assignments, reporting, and configuration support.

• Experience supporting clinical laboratory training, on-the-job training documentation, or competency-related training processes.

• Experience supporting audit responses, regulatory inspections, CAPAs, deviations, and training remediation activities.

• Familiarity with document control, quality records management, and Good Documentation Practices for both electronic and paper records.

• Experience developing or revising training materials, technical documentation, SOP-associated training content, and job aids.

• Experience with reporting and trend analysis to support training compliance and management review.

• New York State Department of Health experience or familiarity is preferred, but not required.    

• Working knowledge of regulated training program administration within a QMS, particularly Veeva LMS.

• Strong understanding of role-based training assignment logic, curricula management, and LMS workflow administration.

• Ability to interpret training needs and convert them into actionable system, process, or documentation updates.

• Ability to assess training data and metrics to identify compliance risks, gaps, and improvement opportunities.

• Ability to work both strategically and tactically, balancing day-to-day administration with broader process improvement efforts.

• Ability to manage sensitive, controlled, and compliance-related documentation with accuracy and attention to detail.

• Ability to support internal clients with a high level of responsiveness, professionalism, and service orientation.

This role operates in a regulated environment and is expected to support training processes in accordance with applicable internal procedures and external requirements, which may include:

• GxP requirements

• ISO 13485

• ISO 15189

• 21 CFR Part 820

• 21 CFR Part 493 (CLIA)

• CAP requirements

• 21 CFR Part 11

• Good Documentation Practices (GDP)    

• Perform and document  troubleshooting, recovery, debugging, and repairs on laboratory systems and equipment. 

• Create and update: procedures, work instructions, guidelines, and testing documents such as installation / operational / verifications, standard operating procedures (SOP)

• Support root cause investigations that drive for resolutions to completion.

• Execute Equipment Lifecycle Management processes and procedures by supporting and maintaining equipment records for traceability purposes in compliance with CLIA/CAP and ISO 13485 requirements.

• Collaborate with validation engineers to draft, review and execute equipment qualification  protocols.

• Recommend and implement changes to ensure ongoing high-quality and efficient engineering operations procedures as part of the continuous improvement process.

• Support the planning and execution of qualification activities ensuring compliance with established procedures and guidelines. 

• Participate and adhere to GRAIL’s policies and guidelines

• Work closely with Compliance, Engineering, Quality and Regulatory to implement and follow the required policies and procedures for the lifecycle of equipments

• Partner cross-functionally to enable effective technology transfer and continuous workflow improvements.

 

• Bachelor’s degree or equivalent in Engineering, Physics, Chemistry, or similar Life Sciences discipline. 

• 0 - 1 years generating technical documentation within a regulated environment

• 0 -1  years experience completing work in accordance with stated deadlines 

• 0 -1  years experience contributing to cross-functional team initiatives

• 0 -1  years technical troubleshooting and root cause analysis experience

• Good to excellent communication skills to work independently and provide internal customer support.

• Good to excellent time management skills to support a fast paced working environment.

• Basic to good knowledge of laboratory equipment and systems.

• Basic to good knowledge creating and interpreting process and material flow diagrams

• Ability to take initiative and independently drive projects to completion with detailed and efficient execution and reporting

• Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, and wear safety gear.

• Occasionally work with dry ice or materials stored at very low temperatures.

• Must be able to stand or sit for long periods of time. 

• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation.

• Must regularly lift and / or move up to 10 pounds.

• Must frequently lift and/or move up to 25 pounds.

• Must occasionally lift and/or move up to 50 pounds.