Senior CQV Engineer – Biopharma Equipment Leader

LSC, Life Science Consultants; Munster; On-site; EUR 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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

Responsibilities

• 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

Skills

CQV leadership

GMP knowledge

Vendor management

Technical writing

Problem solving

Stakeholder communication

Aseptic processing

Lyophilization

CIP/SIP

Isolator technology

Education

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

Job description

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.