Key Position:
C&Q Engineer for a six-month contract
Gain valuable experience in commissioning and qualification of utilities manufacturing equipment, contributing to your future career.
The company has a positive and inclusive culture with high ratings on Great Place to Work and top workplace lists.
With significant investment, they demonstrate their commitment to the community.
Job Role:
Responsible for generating, executing, and approving qualification documents for Direct Impact Systems and commissioning test documents for Not direct Systems.
Core Responsibilities:
* Coordinate and execute C&Q activities
* Develop master lists of C&Q test documents and activities
* Generate C&Q summary reports
* Ensure developed and maintained C&Q schedules
* Generate all C&Q test documents (Plan, FAT, SAT, IV, FT)
* Attend C&Q coordination meetings
* Run business activities such as periodic reviews, cleaning, CAPAs, deviations, change control, risk assessments
* Track and report C&Q status and risks/issues
* Ensure safe and coordinated startup of equipment/utilities
* Apply industry compliance standards/regulations to C&Q activities
* Participate in root cause analysis and investigations
* Highlight compliance issues proactively
* Participate in internal and external audits/inspections
Required Skills:
* BS Degree in engineering/science or technical discipline
* 3 years of Commissioning and Qualification experience, ideally in OSD/pharmaceutical organizations
* Previous experience with clean utility tie-ins to existing systems desirable
* Experience with hygienic piping, process instrumentation, controls, and TOPs advantageous
* Familiarity with risk-based approach to commissioning and qualification preferred
* Project management tools familiarity advantageous
* Adherence to cGMP/cGDP mandatory
* Strong technical writing skills essential
* Proven track record in fast-paced GMP environments
* Self-sufficiency critical
* Strong interpersonal/teamwork skills required