CQV x5

303353

Category:
Engineer Manufacturing
Location:
Cork
Date Posted:
04/07/2022
Days Remaining:
365
Employment Type:
Contract

CQV Engineer (Utilities)

DPS Engineering are now recruiting for a CQV Utilities Engineer for a client located in Cork. Traditionally known as a multinational Medical Device provider, our client is introducing their first pharmaceutical project.

Responsibilities:                                 

  • Generation of qualification risk assessment/testing matrix for qualification protocols and supporting documents in line with User Requirements/Equipment Specifications to cGMP compliance standards.
  • Preparation and approval of Utilities Validation SOPs.
  • Develop, review and execute GMP critical utility Performance Qualification (PQ) protocols and PQ reports for GMP Critical systems e.g. HVAC, RO/PW/WFI, Clean Steam, Clean Compressed Gasses, walk in cold storage.
  • Full oversight of all personnel and contractors participating or executing PQ activities, ensuring all team members are trained and follow the relevant site procedures.
  • Responsible for ensuring documentation being leveraged for PQ testing from project commissioning phase/IQ/OQ are referenced as per associated qualification, referencing procedures.
  • Responsible for validation tasks/actions associated with quality system change controls and investigations where required.
  • Development/Generation of Utilities Validation Master Plan.
  • Periodic review and revalidation assessment.

Requirements:                                    

  • Bachelors Degree in Engineering or equivalent discipline. 
  • 3years + Commissioning Qualification & Validation experience, ideally covering GMP Critical Utilities Equipment.
  • Have the capability and experience to manage Vendors and Contractors supporting PQ activities.
  • Ability to work independently and as part of a team in a cross functional collaborative environment.

DPS is a leading Project Management and Engineering Company delivering Full Service Engineering with a ‘client first’ mentality and personal touch across a range of market sectors: Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up. We have one goal: to deliver more than our clients expect first time, every time.

We’ve been serving industry around the world for 40 years plus, relied on for our agility, original thinking, sound judgement and high-calibre people. What sets us apart is the rapport we build with our clients and the care we take to gain a fundamental understanding of our client’s businesses. We employ over 2400+ people out of our 17 office locations and we serve a broad range of clients ranging from multinational companies to small generic producers. 

DPS Engineering is an Equal Opportunities Employer.

Recruitment Agencies: Please do not reply to this job advert.

 

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