Lead C&Q Engineer

LSC, Life Science Consultants; Munster; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

LSC seeks a Lead C&Q Engineer to head the CQV lifecycle for core process equipment in a cutting-edge biopharma setting. You will own aseptic lines, lyophilizers, CIP/SIP systems, and associated equipment from FAT/SAT through site handover.

You will author and review validation documentation, supervise vendor engagement, and implement risk-based strategies aligned with FDA/EMA guidance. Strong leadership and technical writing are essential.

Formación

• Proven experience leading CQV for core process equipment
• Experience with aseptic processing, lyophilization, CIP/SIP, and isolator technology
• Strong knowledge of GMP standards and regulatory requirements
• Experience implementing risk-based validation and CAPA actions

Responsabilidades

• Lead CQV lifecycle for all core process equipment
• Author, review and approve validation documentation (URS, FAT/SAT, IQ, OQ, PQ)
• Own process systems including aseptic lines, lyophilizers, vessels, CIP/SIP, SUS, and inspection machines
• Manage vendor engagement and coordinate FAT/SAT activities
• Implement risk-based validation strategies aligned with regulatory guidelines
• Lead investigations into deviations and non-conformances, driving CAPA
• Collaborate with Process Eng, Automation, QA, Operations and Projects for commissioning and handover

Conocimientos

CQV leadership

GMP knowledge

Vendor management

Technical writing

Problem solving

Stakeholder communication

Aseptic processing

Lyophilization

CIP/SIP

Isolator technology

Educación

Bachelor's or Master's in Chemical/Process/Mechanical Eng or Biotechnology

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

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:

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.