Senior Validation (CQV) Engineer (Citizen or Permanent Residents only)

Senior Pharmaceutical CQV Engineer
Duration: Full Time Direct Hire
Location: Onsite in various Locations in US

Position Description :

Position Summary

Pharmaceutical Senior CQV Engineer position is a direct hire which is expected to be on-site.

Summary

We are seeking a highly motivated Senior CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical and biotechnology manufacturing facilities. The successful candidate will lead and execute CQV deliverables associated with GMP-regulated process equipment, utilities, automation systems, cleanrooms, and manufacturing operations.

This role requires hands-on technical expertise, strong project coordination skills, and a thorough understanding of FDA and cGMP compliance requirements. The Senior CQV Engineer will work cross-functionally with Engineering, Quality, Manufacturing, Automation, and external vendors to ensure successful project execution and operational readiness within fast-paced life sciences environments.

Key Responsibilities

• Lead and execute CQV activities for pharmaceutical and biotech capital projects.
• Develop and execute:
• Commissioning plans
• IQ/OQ/PQ protocols
• Validation test scripts
• Traceability matrices
• Summary reports
• Support startup and qualification of:
• Process equipment
• Clean utilities
• HVAC systems
• Manufacturing suites
• Automation and control systems
• Coordinate field execution activities with engineering, construction, vendors, and operations teams.
• Perform system walkdowns and turnover package reviews.
• Support deviation investigations, CAPAs, and change control activities.
• Ensure all validation documentation complies with cGMP, FDA, ISPE, and GAMP guidelines.
• Participate in FAT/SAT execution and acceptance activities.
• Support project schedule development and milestone tracking.
• Collaborate with Quality Assurance and Manufacturing teams to support inspection readiness and successful system release.
• Mentor junior CQV engineers and validation specialists as needed.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline.
• 5-10+ years of CQV, validation, or pharmaceutical engineering experience within GMP-regulated environments.
• Strong knowledge of:
• cGMP regulations
• FDA validation requirements
• ISPE Baseline Guides
• GAMP 5 principles
• Experience executing commissioning and qualification for:
• Process equipment
• Utilities
• HVAC systems
• Cleanrooms
• Automation systems
• Experience authoring and reviewing validation lifecycle documentation.
• Strong technical writing and documentation skills.
• Ability to work independently within fast-paced project environments.

Preferred Qualifications

• Experience in biologics, sterile manufacturing, fill-finish, or aseptic processing environments.
• Previous consulting experience within life sciences industries preferred.
• Familiarity with:
• DeltaV
• MES systems
• SCADA platforms
• Kneat or electronic validation systems
• PMP certification or equivalent project leadership experience is a plus.
• Strong client-facing communication and leadership skills.

Additional Skills & Competencies

• Excellent organizational and multitasking abilities
• Strong problem-solving and analytical skills
• Ability to manage multiple priorities and deadlines
• Comfortable working in both office and field environments
• Ability to travel to client sites as required