Lead CQV Engineer - GMP/Validation Strategy Pro

Creative Solutions Services, LLC; Wichita (KS); On-site; USD 110,000 - 170,000; Full time

Job summary

Creative Solutions Services, LLC in Wichita, KS is seeking an experienced Senior CQV Engineer to lead commissioning, qualification and validation activities for pharmaceutical manufacturing facilities.

You will develop CQV plans and protocols (URS, DQ, FAT, SAT, IQ, OQ, PQ), review drawings and vendor packages, and coordinate with Engineering and Quality to ensure GMP/GxP compliance.

Required: 7–10+ years in CQV/validation in regulated industries, plus strong writing and leadership skills.

Qualifications

• 7–10+ years of CQV/validation in regulated industries
• Strong GMP/GxP validation knowledge
• Excellent technical writing and communication skills

Responsibilities

• Lead CQV activities for equipment, utilities, facilities, and systems.
• Develop and execute URS, DQ, FAT, SAT, IQ, OQ, and PQ documentation and protocols.
• Develop CQV plans, validation strategies, protocols, reports, and traceability documentation.
• Review engineering specs, P&IDs, drawings, equipment docs, and vendor packages.
• Coordinate FAT/SAT activities with vendors, Engineering, Quality, and project teams.
• Perform equipment and utility qualification activities per approved procedures.
• Develop and execute risk assessments, including FMEA and criticality assessments.
• Ensure validation activities align with GMP/GxP, FDA, EU GMP, GAMP 5, ISPE.

Skills

CQV experience

GMP/GxP knowledge

Technical writing

Leadership

Problem solving

Quality Assurance

Education

Bachelor's in Engineering

Job description

Creative Solutions Services, LLC in Wichita, KS is seeking an experienced Senior CQV Engineer to lead commissioning, qualification and validation activities for pharmaceutical manufacturing facilities.

You will develop CQV plans and protocols (URS, DQ, FAT, SAT, IQ, OQ, PQ), review drawings and vendor packages, and coordinate with Engineering and Quality to ensure GMP/GxP compliance.

Required: 7–10+ years in CQV/validation in regulated industries, plus strong writing and leadership skills.