CIP C&Q Lead

Stark Pharma Solutions Inc; Cary (NC); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

CIP commissioning

CIP qualification

GMP knowledge

Communication

Teamwork

Troubleshooting

Descripción del empleo

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position

CIP C&Q Lead

Location

North Carolina

Duration

Long Term

Job Overview

We are seeking an experienced CIP C&Q Lead with strong experience in Clean-In-Place systems, commissioning, qualification, and cleaning cycle development within pharmaceutical or biotech environments.

Key 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.

Required Qualifications

• Strong experience in CIP commissioning and qualification.
• Hands-on experience with pharmaceutical or biotech CIP systems.
• Experience with cleaning cycle development and optimization.
• Experience reviewing P&IDs and engineering documentation.
• Experience developing URSs, risk assessments, test plans, and IOQ protocols.
• Experience with FAT, SAT, automation functional testing, and field execution.
• Knowledge of GMP requirements and regulated manufacturing environments.
• Experience with LOTO and field-based commissioning activities.
• Strong troubleshooting and problem-solving skills.
• Good communication and teamwork skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.