Senior CQV Engineer/Manager

Senior CQV Engineer/Manager

Posted 3 days ago by IT Minds LLC

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Negotiable
Undetermined
Undetermined
Remote or Hybrid in Indianapolis, Indiana
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Automation Computer Systems Computer System Validation Data Integrity DeltaV Distributed Control System Informatics Management SAP Applications Supervisory Control And Data Acquisition (SCADA) Traceability Matrix Verification And Validation

Summary: The Senior CQV Engineer/Manager role involves leading and supporting validation activities in highly regulated environments such as pharmaceuticals and biotechnology. The position requires ensuring GMP compliance across various systems and processes while developing validation strategies. The candidate will collaborate with multiple teams and provide leadership to validation engineers. This is a long-term contract position with flexible working arrangements based on project requirements.

Key Responsibilities:

  • Lead and support Commissioning, Qualification, and Validation (CQV) activities for facilities, utilities, equipment, laboratory systems, and manufacturing processes.
  • Develop and execute Validation Master Plans (VMPs), risk assessments, traceability matrices, and validation protocols.
  • Author, review, and approve IQ/OQ/PQ protocols and validation summary reports.
  • Coordinate commissioning and qualification activities for cleanrooms, HVAC systems, water systems (PW/WFI), clean steam, compressed gases, and manufacturing equipment.
  • Support FAT, SAT, startup, and operational readiness activities.
  • Manage deviations, investigations, CAPAs, and change controls.
  • Ensure compliance with FDA, EMA, MHRA, GAMP 5, Annex 11, 21 CFR Part 11, and Data Integrity requirements.
  • Collaborate with Engineering, Manufacturing, Quality Assurance, Automation, Regulatory Affairs, and Validation teams.
  • Support regulatory inspections, audits, and remediation activities.
  • Provide leadership and mentoring to validation engineers and CQV team members.

Key Skills:

  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field.
  • 10+ years of CQV / Validation experience within pharmaceutical, biotechnology, medical device, or life sciences industries.
  • Strong experience with GMP, cGMP, and regulatory compliance requirements.
  • Extensive hands-on experience with Commissioning, Qualification & Validation (CQV), IQ / OQ / PQ Execution, Validation Master Plans (VMP), Risk Assessments, Traceability Matrix Development, Deviation, CAPA, and Change Control Management, GMP Documentation and Compliance.
  • Technical experience in Cleanroom Qualification, HVAC Qualification, Water Systems (PW/WFI), Clean Steam Systems, Compressed Air/Gas Systems, Manufacturing Equipment Qualification, Packaging Equipment Validation, Laboratory Equipment Qualification, Process Validation.
  • Experience validating systems such as MES, LIMS, Empower, TrackWise, Veeva, SAP, DeltaV, SCADA Systems, Laboratory Informatics Systems.
  • Preferred experience in Pharmaceutical or Biotechnology Manufacturing, Cell & Gene Therapy, Biologics Manufacturing, Vaccine Manufacturing, Greenfield Facility Startups, Large Capital Projects, Regulatory Inspection Readiness.
  • Preferred certifications include PMP, CQV / Validation Certifications, ASQ Certifications (CQE/CQA), ISPE Training, Lean Six Sigma Green Belt or Black Belt.
  • Must-have skills include CQV, GMP / cGMP Compliance, IQ/OQ/PQ, Validation Master Plans (VMP), Risk Assessments, Traceability Matrix, CAPA & Deviation Management, Cleanroom / HVAC Qualification, Utilities Qualification (PW/WFI/Clean Steam), Computer System Validation (CSV), FDA / EMA / GAMP 5 Compliance.

Salary (Rate): undetermined

City: Indianapolis

Country: United States

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

Job Title: Senior CQV Engineer/Manager

Location: Remote / Hybrid / Onsite (Depending on Project Requirements)

Duration: Long-Term Contract

Position Overview

We are seeking an experienced CQV (Commissioning, Qualification & Validation) professional to support and lead validation activities within highly regulated pharmaceutical, biotechnology, and life sciences environments. This role will be responsible for ensuring GMP compliance across facilities, utilities, equipment, manufacturing processes, and computerized systems while driving validation strategies and project execution.

Key Responsibilities

  • Lead and support Commissioning, Qualification, and Validation (CQV) activities for facilities, utilities, equipment, laboratory systems, and manufacturing processes.
  • Develop and execute Validation Master Plans (VMPs), risk assessments, traceability matrices, and validation protocols.
  • Author, review, and approve IQ/OQ/PQ protocols and validation summary reports.
  • Coordinate commissioning and qualification activities for cleanrooms, HVAC systems, water systems (PW/WFI), clean steam, compressed gases, and manufacturing equipment.
  • Support FAT, SAT, startup, and operational readiness activities.
  • Manage deviations, investigations, CAPAs, and change controls.
  • Ensure compliance with FDA, EMA, MHRA, GAMP 5, Annex 11, 21 CFR Part 11, and Data Integrity requirements.
  • Collaborate with Engineering, Manufacturing, Quality Assurance, Automation, Regulatory Affairs, and Validation teams.
  • Support regulatory inspections, audits, and remediation activities.
  • Provide leadership and mentoring to validation engineers and CQV team members.

Required Qualifications

  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field.
  • 10+ years of CQV / Validation experience within pharmaceutical, biotechnology, medical device, or life sciences industries.
  • Strong experience with GMP, cGMP, and regulatory compliance requirements.
  • Extensive hands-on experience with:
    • Commissioning, Qualification & Validation (CQV)
    • IQ / OQ / PQ Execution
    • Validation Master Plans (VMP)
    • Risk Assessments
    • Traceability Matrix Development
    • Deviation, CAPA, and Change Control Management
    • GMP Documentation and Compliance

Technical Experience Required

  • Cleanroom Qualification
  • HVAC Qualification
  • Water Systems (PW/WFI)
  • Clean Steam Systems
  • Compressed Air/Gas Systems
  • Manufacturing Equipment Qualification
  • Packaging Equipment Validation
  • Laboratory Equipment Qualification
  • Process Validation

Computer System Validation (CSV)

Experience validating one or more of the following systems:

  • MES
  • LIMS
  • Empower
  • TrackWise
  • Veeva
  • SAP
  • DeltaV
  • SCADA Systems
  • Laboratory Informatics Systems

Preferred Experience

  • Pharmaceutical or Biotechnology Manufacturing
  • Cell & Gene Therapy
  • Biologics Manufacturing
  • Vaccine Manufacturing
  • Greenfield Facility Startups
  • Large Capital Projects
  • Regulatory Inspection Readiness

Preferred Certifications

  • PMP
  • CQV / Validation Certifications
  • ASQ Certifications (CQE/CQA)
  • ISPE Training
  • Lean Six Sigma Green Belt or Black Belt

Must-Have Skills

  • CQV (Commissioning, Qualification & Validation)
  • GMP / cGMP Compliance
  • IQ/OQ/PQ
  • Validation Master Plans (VMP)
  • Risk Assessments
  • Traceability Matrix
  • CAPA & Deviation Management
  • Cleanroom / HVAC Qualification
  • Utilities Qualification (PW/WFI/Clean Steam)
  • Computer System Validation (CSV)
  • FDA / EMA / GAMP 5 Compliance

Best Regards,

Satya Satish J | Technical Recruiter | IT Minds LLC |

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