What are the responsibilities and job description for the Senior CQV Engineer/Manager position at IT Minds LLC?
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 |