- Support C&Q activities from project initiation to closeout.
- Oversee, coordinate and perform detailed field commissioning services for all types of facilities including laboratories, cleanrooms, manufacturing, and pilot plants.
- Review functional, design and testing documentation from suppliers/contractors to ensure compliance to cGMP and Good Documentation Practices.
- Review the Vendor/Contractor quality documentation for completeness and correctness and coordinate activities to ensure compliance to the C&Q plan.
- Prepare detailed User Requirements Specifications (URS), Commissioning & Qualification Plans and Specifications, installation checklists and functional test procedures.
- Perform Design Verification (Design Qualification) and execution according to agreed format.
- Prepare IQ/OQ procedures and protocols and/or supplementing documentation provided by the Suppliers/Contractors. Participate in FAT, SAT, IQ and OQ activities and prepare related reports.
Qualifications and Skills
- The desired candidate will be ambitious and flexible; have a talent for efficiency and process improvement, as well as a strong desire to succeed.
- Good organizational and planning skills with the ability to direct a team through the execution of the C&Q process.
- Ability to develop strong working relationships with the internal and external stakeholders and works well within a collaborative team environment.
- Strong verbal and written communication skills in English. Experience coordinating with both owners and contractors as well as the ability to lead project meetings are necessary.
- Ability to read and understand building drawings, specifications, and submittals.
- Must be proficient in the use of computers and Microsoft Office products (Word, Excel, Power Point). Familiarity with AutoCad and/or Revit will be considered an asset.
- 5 years or more in the commissioning and qualification of biotech, pharma, medical devices, and/or semiconductor industries, with the work including both building systems for HVAC (air and hydronic), controls, plumbing, laboratory equipment, fire protection, security, and/or electrical systems and process systems.
- B.S degree in engineering preferred.
Salary and Benefits:
This is a full time, exempt position with a competitive salary and benefits package which includes medical and dental coverage, as well as 401(k) retirement and profit-sharing programs.