C&Q Engineer

Desired Skills: commissioning,qualification,validation,project management

Description:

PE Global is currently recruiting for a C&Q Engineer on behalf of a leading pharmaceutical company based in Mayo. This is an initial 9 month contract role.

Job Summary:

• 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.

• Joining a team of 5 supporting across biologics and med device, will be working on a particular project to implement new clean utilities systems for the Allotrope product. 

Main systems in scope of support:

• WFI Distillation, Storage and Distribution
• Purified Water
• POU Coolers
• Partswasher  
• Sterilization Autoclave
• VHP
• Freezers
• Facility qualification

Education and Experience:

• BS Degree in engineering, science or technical discipline required.
• 3 years of Commissioning and Qualification experience, ideally working in medical device or pharmaceutical organization.
• Previous experience with clean utilities, hygienic piping, process instrumentation, controls and TOPs is mandatory.
• Familiarity with the risk-based approach to commissioning and qualification preferred. Familiarity with project management tools is advantageous.
• Kneat validation system knowledge is an advantage.
• Previous experience with Clean Utility tie-ins to existing systems is desirable (i.e Upgrading existing purified water skid to support a new tank).
• Working knowledge of sanitary equipment, hygienic piping, process instrumentation and controls is desired Familiarity with the risk-based approach to commissioning and qualification preferred. Familiarity with project management tools is advantageous.
• 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.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***