Careers

Lead C&Q Clean Utilities Engineer

Eastgate Engineering is seeking to recruit a Lead Clean Utilities C&Q Engineer for a Dublin, Ireland, based Pharmaceutical project.


Main function:

Lead the execution of all aspects relating to commissioning and qualification of Clean Utilities, ensuring compliance with all applicable regulatory and internal Quality standards and industry best practice.

Position roles & responsibilities:

• Lead and direct the Clean Utilities C&Q execution team based at a Pharmaceutical Facility, Dublin, Ireland and manage the C&Q documentation lifecycle.

• Lead a team of commissioning technicians and plan work activities in line with project schedule. Develop and populate relevant C&Q documentation for project handover.

• Review, develop and take ownership of the required processes relating to C&Q ensuring compliance with all applicable regulatory, functional and internal Quality standards and industry best practice with zero impact to the process development, facilities or operations functions.

• Develop progress reports and highlights possible constraints and issues for Q&C Manager

• Developing & implementing compliant processes for VMP, VPP‘s, specifications, DQ, FAT/SAT, IQ, OQ, PQ & PPQ, requalification and periodic review.

• Work with the Commissioning and Qualification Manager to plan and schedule the required qualification activities to maintain project schedule by the most appropriate personnel.

• Manage and support service or equipment vendors when undertaking qualification as required to ensure that applicable standards are adhered to.

• Liaise with discipline leads to coordinate activities for efficient execution of Q&C activities.

• Approve acceptance of installations for turnover from the construction group to commissioning.

Ensure all PTW and mechanical isolations are in place to perform Q&C works related to mechanical Utilities.

Organisation Structure: The Lead Clean Utilities Q&C Engineer reports to the Commissioning and Qualification Manager.

Candidate Profile

Role requirements:

Significant experience of leading C&Q teams in the pharmaceutical industry essential including bio-pharmaceutical and utility qualification activities and documentation requirements. 7 – 10 years in similar role preferred

• Degree level qualification, mechanical engineering discipline preferred.

• Able to influence, persuade, negotiate and compromise.

• Proven ability to lead a Utilities orientated Q&C team

• Understands that position is the technical leader for Utilities C&Q activities on this project.

Interested applicants can apply at info@eastgateengineering.com or visit www.eastgateengineering.com . Applications will be treated as confidential

 

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