JOB TITLE 

CQV Engineer

ABOUT THE ROLE  

We are seeking a highly skilled and motivated CQV  Engineer to lead and execute commissioning qualification, and validation (CQV), actitvities across our GMP manufacturing and laboratory environment.  In this role you will ensure that equipment, facilites, utilities, automation systems and supporting infrastructure are designed, installed, tested, and maintained in compliance with cGMP requirements and regualtory environment. 

You will play a keep role in supporting  capital projects, facility expansions, process improvements, and equipment implementation initiatives.  This role collaborates cross-fucntionally with Engineering, Manufacturing, Quality, Automation, Process Development, and external vendors to ensure successful project execution and operational readiness.

 MAIN TASKS & RESPONSIBILITIES  

  • Lead commission, qualification, and validation activities for GMP equipment, utilities, facilities, automation systems, and infrastructure.
  • Develop and execute CQV documentation including Validation Plans, Risk Assessments, Commissioning Protocols, IQ/OQ/PQ protocols, Traceability Matrices, and Final reports.
  • Author, review, an approve technical documents, including SOP's, change controls, deviations, CAPAs, and validation lifecycle documentation.
  • Support implementation and qualificaition of manufacturing equipment, clean utilities, HVAC systems, laboratory equipment, and computerized systems.
  • Coodinate startup, shakedown, commissioning, and qualification activities to supprt operational readiness and project timelines.
  • Ensure all validation acitivies comply with cGMP regulations, data integrity standards and company procedures.
  • Partner cross-functionally with Quality Assurance, Manufacturing, Engineering, Automation, Facilties, Metrology, and Process Development teams.
  • Provide technical leadership, mentoring, and guidance to junior engineers and validation resources.
  • Support automation and computerized systems validation (CSV) including system assessments and lifecycle documentation.
  • Participate in FATs, SATs, design reviews, construction walkdowns, and turnover package development.
  • Support change management activities related to equipment, utilities, and system modifications.
  • Drive continuous improvement initiatives relted to validation processes, documentation, and efficiency.
  • Collaborate with contractors, venfors, and system integrators to ensure compliant and timely project delivery.
  • Support audits, inspections, and regualtory interactions as required.
  • Address technical and project challenges to minimize delays and business impact.
  • Support capital projects and strategic initiatives tied to manufacturing expansion and operational readiness.

 SKILLS AND EXPERIENCE 

  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline required.
  • 6+ years CQV experience in a GMP regulated biotech, pharmaceutical, medical device, or life sciences environment.
  • Proven experiene leading validation for:
    • GMP manufacturing equipment
    • Clean utilities and HVAC systems
    • Laboratory systems and facility infrastructure.
  • Strong knwowledge of cGMP regulations, FDA/EU expectations, and validation lifecycle principles.
  • Experience authoring and executing validation documentation (IQ/OQ/PQ, risk assessments, traceability matrices, reports).
  • Experience supporting capital projects, facility expansions, equipment installations, and technolgy transfers.
  • Experience with FATs, SATs, commissioning, and turnover packages.
  • Familiarity with computerized system validation (CSV), automation systems, and data integrity principles preferred.
  • Fill/Finish manufacturing experience preferred.
  • Strong understanding of engineering systems (HVAC, process equipment, utilities, automation).
  • Ability to manage multiple projects and priorities in a fast-paced environement.
  • Experience supporting audits and regualtory inspections.
  • Strong technical writing, communication, and problem-solving skills.
  • Demonstrated leadership and mentoring capabilities. 
  • Professional certifications (PMP, CQE, CVP) are a plus.
  • Excellent written and verbal communication skills
  • Strong analytical and problem-solving abilities.
  • Ability to influence and collaborate cross-functionally.
  • Effective time management and prioritization skills.
  • Ability to manage multiple priorities simultaneously.

 WORK ENVIRONMENT

This is an office-based position that will require some non-standard working hours including early morning or later evening teleconferences to support prospective and current clients.

WHAT WE OFFER

Our core values of Respect, Reliability, Collaboration and Excellence shape every aspect of our work and our interactions with all our stakeholders. We seek individuals who are respectful, considerate and honest, value diversity and show integrity in their daily work. Our culture thrives on reliability, ensuring we consistently deliver on our promises and meet the expectations of our stakeholders through operational excellence. We believe in the power of collaboration, fostering an agile environment through teamwork and active listening. Our relentless pursuit of excellence drives us to deliver high-quality products and services, while maintaining a supportive and inclusive atmosphere where every team member is recognised and valued. Join us to be part of a community that is committed to mutual success and high standards.

LOCATION 

 This position is fully on-site and requires five days per week at our Watertown, MA location.

 

Annual Base salary range: $78,000 - $110,000

 

 

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