We are seeking a seasoned C&Q Engineering Specialist to lead the development and execution of commissioning and qualification projects. With a focus on ensuring compliance with Good Manufacturing Practice (GMP) regulations, this individual will oversee all aspects of C&Q activities for clean utilities, facilities, and process equipment in high-impact capital projects.
Key Responsibilities:
* Create and implement comprehensive C&Q plans, protocols, and documentation
* Develop and execute testing strategies, including FAT/SAT/IV/FT tests
* Spearhead risk assessments and mitigation efforts to ensure system readiness
* Supervise and coordinate cross-functional teams to achieve project milestones
Requirements:
* Minimum 3 years of experience in engineering or C&Q within the pharmaceutical/biotechnology industry
* Bachelor's degree in engineering or equivalent field
* Demonstrated knowledge of GMP regulations, risk-based qualification, and quality management systems
* Proven leadership and communication skills to engage senior stakeholders and drive results
Benefits:
* Pan-industry recognition for expertise in C&Q engineering
* Collaborative work environment with dynamic cross-functional teams
* Opportunities for professional growth and skill development