Senior CQV Engineer

Desired Skills: commissioning,validation,qualification,HVAC

The role:

PE Global is currently recruiting for a Senior CQV Engineer (HVAC) on behalf of a leading pharmaceutical company based in Dublin. This is an initial 12-month contract role.

Overview:

Prepare and execute the site commissioning and validation testing for HVAC & Clean Rooms in the Sterile Drug Product Facility in alignment with site and global procedures.

Responsibilities:

• Development and execution of CQV testing documentation for HVAC & Clean Rooms for the Sterile Drug product facility.
• Responsible for meeting key project deliverables for safety, CQV schedule management and quality of project related documentation/electronic records for HVAC & Clean Rooms assigned.
• Responsible for ensuring GMP Clean Rooms, Cold Rooms and HVAC Equipment systems are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
• Responsible for ensuring that all non GMP HVAC and systems are tested in compliance with project related standards from a commissioning perspective.
• Deviation management associated with the assigned HVAC & Clean Rooms.
• Risk Management – Identifies and categorizes CQV risks according to impact on commissioning and qualification. Generation of action plans to mitigate qualification risks.
• Execution of FAT testing for assigned equipment.
• Coordination with vendors & contractors during execution of Commissioning & Qualification documents.
• Ensuring all assigned training is executed on time to meet site metrics.

Education and Experience:

• The ideal candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline along with a minimum of 3-5 years of experience within the pharmaceutical industrial ideally with familiarity with Sterile Drug Product filling line experience.
• Demonstratable capacity to implement a project CQV strategy, effectively execute the CQV testing approach for assigned from initiation to completion.
• CQV project lifecycle experience from end-to-end design through to C&Q and handover.
• Understands the project management process; programming, scope development, design development, implementation, and project closeout.
• Demonstrable experience of performing as part of diverse team of CQV professionals/ contractors to deliver on tasks safely, with quality focus, on time and within budget.
• Experience in CQV of Drug Substance/Drug product sterile manufacturing HVAC & Clean Rooms with integrated automation platforms.
• Experience in startup facilities, energizing equipment, executing startup safety documents i.e.. LOTO, STW, PSSR, etc.
• Solid background of document preparation, execution, and task planning on CQV projects with a demonstrated record of on time performance.
• Excellent communication skills and the ability to influence others.
• Demonstratable experience working in teams in a matrix environment to deliver CQV elements.
• Experience with a digital validation platform, such as ValGenesis or Kneat.
• Innovation – seeks innovative approaches for commissioning and qualification approach working within policies and Regulatory expectations using operational excellence tools in improving approaches for these activities.

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***