Orion Group Life Sciences are currently recruiting a C&Q Engineer on behalf of our Multinational Biopharmaceutical client based in Westport on an initial 9-month contract (with potential to extend).
 
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. 
 
Requirements:

• 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.
• 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.
• The candidate must be able to work independently with limited supervision – self-sufficiency is critical. They must demonstrate strong interpersonal & teamwork skills. Must be flexible to support unexpected project demands and maintain the overall program schedule.

Main systems in scope of support:

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

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.