CIP C&Q Lead - Pharma Clean-In-Place Expert (NC)

Stark Pharma Solutions Inc; Cary (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking an experienced CIP C&Q Lead to drive commissioning and qualification for CIP systems in a pharmaceutical or biotech setting.

You will develop cleaning cycles, review P&IDs, and create URSs and IOQ protocols while coordinating cross‑functional teams to ensure GMP standards and project success. The role demands hands-on field execution, safety compliance, and collaboration with Engineering, Automation, Quality, and SME teams to deliver compliant final reports

Qualifications

• Strong experience in CIP commissioning and qualification.
• Hands-on experience with pharmaceutical/biotech CIP systems.
• Experience with cleaning cycle development and optimization.
• Experience reviewing P&IDs and engineering documentation.
• Experience developing URSs, risk assessments, test plans, IOQ protocols.
• Experience with FAT, SAT, automation testing, and field execution.
• GMP knowledge and regulated manufacturing exposure.
• Experience with LOTO and field-based commissioning activities.
• Strong communication and teamwork skills.

Responsibilities

• Lead commissioning and qualification activities for CIP systems.
• Develop and optimize CIP cleaning cycles and critical parameters.
• Review P&IDs and engineering documentation.
• Develop URSs, quality risk assessments, and commissioning test plans.
• Develop and execute IOQ protocols and final summary reports.
• Coordinate automation functional testing and system verification.
• Support CIP systems from construction through completion of C&Q activities.
• Perform field activities including safety checks, LOTO, protocol execution, and issue resolution.
• Participate in FAT and SAT activities as required.
• Work closely with Engineering, Automation, Quality, and SME teams.
• Ensure systems meet project requirements, safety standards, and GMP expectations.
• Support the safe handling of caustic cleaning solutions.

Skills

CIP commissioning

CIP qualification

GMP knowledge

Communication

Teamwork

Troubleshooting

Job description

Stark Pharma Solutions Inc. is seeking an experienced CIP C&Q Lead to drive commissioning and qualification for CIP systems in a pharmaceutical or biotech setting.

You will develop cleaning cycles, review P&IDs, and create URSs and IOQ protocols while coordinating cross‑functional teams to ensure GMP standards and project success. The role demands hands-on field execution, safety compliance, and collaboration with Engineering, Automation, Quality, and SME teams to deliver compliant final reports