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Commissioning and Qualification Engineer
Employer undisclosedRole managed by a recruiter
Responsible for generating and executing qualification documents for direct impact systems and creating commissioning test documents for non-direct systems in a biopharmaceutical organization.
22d ago
€80,000
Experienced (8-12 years), Expert & Leadership (13+ years), Intermediate (4-7 years)
Contractor
Cork, County Cork, Ireland
Onsite
Role
What you would be doing
dispensing equipment
qualification docs
commissioning tests
system qualification
facility utility
equipment systems
Role will be responsible for the Generation, Execution and Approval of Qualification documents for Direct Impact Systems (Facility, Utility and Equipment) and the generation of Commissioning Test documents for Not direct Systems.
- Dispensing Equipment including down flow booth, matcom stations, PTS powder systems
What you bring
commissioning
risk-based
bs degree
clean utility
technical writing
cgmp
- Familiarity with the risk-based approach to commissioning and qualification preferred. Familiarity with project management tools is advantageous.
- Familiarity with project management tools is advantageous.
- Previous experience with Clean Utility tie-ins to existing systems is desirable (i.e Upgrading existing purified water skid to support a new tank).
- Previous experience with clean utilities, hygienic piping, process instrumentation, controls and TOPs is advantageous.
- They must demonstrate strong interpersonal & teamwork skills.
- Working knowledge of sanitary equipment, hygienic piping, process instrumentation and controls is desired
- BS Degree in engineering, science or technical discipline required.
- Tumble mixer equipment including CIP SKID
- Adherence to cGMP and cGDP is mandatory. Strong technical writing skills are essential. The candidate must have a proven track record working within a fast paced GMP environment.
- 3 years of Commissioning and Qualification experience, ideally working in OSD or pharmaceutical organization.
- Must be flexible to support unexpected project demands and maintain the overall program schedule.
- The candidate must be able to work independently with limited supervision – self-sufficiency is critical.
- Previous experience with clean utility tie-ins to existing systems is desirable.
- Familiarity with the risk-based approach to commissioning and qualification preferred.
- Utilities – compressed air
Information not given or found
Interview process
Information not given or found
Visa SponsorshipInformation not given or found
Security clearance- adherence to cgmp and cgdp is mandatory.
Your recruiter
Your recruiting firm
- Founded in 2019 by a trio of entrepreneurs with a mission to consolidate boutique family-owned service brands.
- Partnerships include Jackson Mechanical and specialized platforms in chiller, refrigeration, controls, and heavy mechanical.
- Typical projects include multi-site retail HVAC roll-outs, preventive maintenance contracts, and large-scale landscape and snow-management programs.
- Commercial landscaping services under its SunWorks banner manage grounds for corporate campuses and distribution hubs nationwide.
- Its facilities maintenance network offers interior handyman, roofing, fencing, plumbing, locksmith, and exterior lot care with tech-driven coordination.
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