Lead C&Q Engineer

LSC, Life Science Consultants; Munster; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

LSC Life Science Consultants in Ireland seeks a Lead C&Q Engineer to drive full-cycle Commissioning and Qualification for critical biopharma processing equipment, from FAT/SAT through site handover, working with multidisciplinary teams.

The role calls for extensive CQV leadership in aseptic fill-finish lines, lyophilizers, CIP/SIP, and regulatory alignment with FDA/EMA, EU Annex 1, and data integrity. Prior contract experience and strong vendor management are essential.

Formación

• Experience leading CQV projects in biopharma or GMP settings.
• Aseptic processing, lyophilization, CIP/SIP, and isolator tech knowledge.
• Familiarity with GMP standards (FDA/EMA), EU Annex 1, ASTM E2500, data integrity.

Responsabilidades

• Lead CQV lifecycle for core process equipment, from FAT/SAT to site handover.
• Author and review validation docs (URS, FAT/SAT reports, IQ/OQ/PQ).
• Own process system CQV packages (aseptic lines, lyophilizers, vessels, CIP/SIP).
• Manage vendor engagement and coordinate FAT/SAT activities.
• Implement risk-based validation strategies and drive CAPA actions.
• Collaborate with Process Engineering, Automation, QA, Operations, and Projects.

Conocimientos

CQV leadership

biopharma GMP experience

aseptic processing

CIP/SIP

FDA/EMA regulatory knowledge

vendor management

technical writing

Educación

Bachelor's or Master's in Chemical/Process Engineering or related

Descripción del empleo

Lead C&Q Engineer

Join a dynamic project during a pivotal phase of construction, commissioning, qualification, and validation as a Lead C&Q Engineer. This is a unique opportunity to take the helm of full-cycle commissioning and qualification processes for critical process manufacturing equipment within a cutting-edge biopharmaceutical environment. Lead and shape the CQV strategy, ensuring systems operate flawlessly from FAT/SAT to site handover, while working closely with multidisciplinary teams to deliver excellence.

Key Responsibilities:

• Lead and oversee the CQV lifecycle for all core process equipment
• Author, review, and approve validation documentation (URS, FAT/SAT reports, IQ, OQ, PQ protocols)
• Take technical ownership of process systems-including aseptic fill-finish lines, lyophilizers, vessels, CIP/SIP systems, SUS, and inspection machines
• Manage vendor engagement and coordinate FAT/SAT activities
• Implement risk-based validation strategies aligned with industry standards and regulatory guidelines
• Lead investigations into deviations and non-conformances, driving CAPA actions
• Collaborate with Process Engineering, Automation, QA, Operations, and Project teams for seamless commissioning and handover

Required Skills:

• Proven experience in leading process equipment CQV within biopharmaceutical or GMP environments
• Deep knowledge of aseptic processing, lyophilization, formulation, CIP/SIP, and isolator technology
• Strong understanding of global GMP standards, FDA/EMA requirements, EU Annex 1, ASTM E2500, and data integrity principles
• Excellent vendor management and leadership skills, with experience guiding junior engineers
• Proficient in technical writing, documentation, and stakeholder communication
• Proactive problem-solving ability and adaptability to high-paced projects

Preferred Education and Experience:

• Bachelor's or Master's degree in Chemical/Process, Mechanical Engineering, Biotechnology, or related field
• Over 7 years of CQV experience in the biopharmaceutical sector
• Demonstrable track record leading process equipment CQV packages on major capital projects

If you're ready to lead ambitious projects and make a tangible impact in the life sciences sector, we want to hear from you-bring your expertise and drive to our innovative team today!

WHY LSC?

LSC work exclusively in the Life Sciences sector. Founded and run by contractors, we understand contracting first-hand and have created a unique approach to make the process as smooth as possible, so you can focus on delivering your best work. With over 23 years' experience supporting the industry, we bring deep sector knowledge and long-standing client relationships. At LSC, we partner with you for the long term, not just the duration of your contract. We are committed to building lasting relationships and will work closely with you to ensure you are placed on projects that challenge, develop, and reward you throughout your career.

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity, you will need to hold a Stamp 1G or Stamp 4 visa to apply. Find out more about working with LSC at lscconnect.com