CQV Engineer

LSC, Life Science Consultants; Dublin; On-site; EUR 83,000 - 111,000; Full time

Job summary

LSC, Life Science Consultants, seeks a CQV Engineer to join a Dublin-based biopharmaceutical company focused on discovering, developing, and delivering innovative medicines. Minimum 5+ years’ CQV experience in pharma/biotech, preferably in Sterile Drug Product manufacturing, is required.

You will support CQV lifecycle activities from design through C&Q and handover, with qualification of GMP equipment and integrated automation. Experience with Kneat or ValGenesis is preferred.

Qualifications

• 5+ years of pharmaceutical industry experience, ideally within Sterile Drug Product manufacturing.
• Strong CQV lifecycle experience from design through C&Q and handover, with experience qualifying GMP equipment and integrated automation.
• Experience with electronic validation platforms Kneat or ValGenesis.

Responsibilities

• Develop and execute CQV testing documentation for Benchtop Equipment and Manual Inspection Booths within a Sterile Drug Product facility.
• Execute commissioning and qualification activities in line with GMP, company procedures and EU/FDA regulatory requirements.
• Manage CQV deviations, identify qualification risks and develop appropriate mitigation/action plans.
• Execute FAT testing and leverage results into the overall qualification process for assigned equipment and utilities.
• Ensure CQV documentation and electronic records are completed to the required quality standards and project timelines.
• Work closely with the Area CQV Lead and wider project team to deliver CQV activities safely, on schedule and to a high standard.

Skills

CQV experience

Sterile drug product manufacturing

Documentation & execution

Education

Degree in Scientific/Engineering field

Tools

Kneat

ValGenesis

Job description

LSC have a great contract opportunity for a CQV Engineer to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life. If you have 5+ years of CQV experience within the pharmaceutical or biotechnology industry, ideally within Sterile Drug Product manufacturing, and are ready for your next challenge, this could be the perfect opportunity for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

• Develop and execute CQV testing documentation for Benchtop Equipment and Manual Inspection Booths within a Sterile Drug Product facility.
• Execute commissioning and qualification activities in line with GMP, company procedures and EU/FDA regulatory requirements.
• Manage CQV deviations, identify qualification risks and develop appropriate mitigation/action plans.
• Execute FAT testing and leverage results into the overall qualification process for assigned equipment and utilities.
• Ensure CQV documentation and electronic records are completed to the required quality standards and project timelines.
• Work closely with the Area CQV Lead and wider project team to deliver CQV activities safely, on schedule and to a high standard.

ABOUT YOU - ARE YOUR SKILLS A MATCH?

• Degree in a Scientific, Technical or Engineering discipline with 5+ years' pharmaceutical industry experience, ideally within Sterile Drug Product manufacturing.
• Strong CQV lifecycle experience from design through C&Q and handover, with experience qualifying GMP equipment and integrated automation.
• Strong CQV documentation and execution experience, with previous use of an electronic validation platform such as Kneat or ValGenesis preferred.

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!