CQ Lead

Walker Cole International is supporting a major pharmaceutical manufacturing project in Southern Germany in the appointment of a Commissioning & Qualification Lead for a long-term engagement.

This role will lead commissioning, qualification, and validation activities for aseptic fill-finish operations, with a focus on automated filling lines within a GMP-regulated environment.

Key responsibilities:

• Lead CQV activities for filling lines, isolators, and associated aseptic equipment.
• Develop and manage validation documentation (FAT, SAT, IQ, OQ, PQ).
• Drive filling line optimisation to improve performance and compliance.
• Act as CQV project lead, coordinating cross-functional teams.
• Provide SME support for filling line systems (e.g. Optima and similar).
• Manage deviations, change controls, and risk assessments.
• Support audits, inspections, and QA activities onsite.
• Liaise with vendors and stakeholders to ensure project delivery.

Required experience and skills:

• 10+ years’ CQV experience in pharmaceutical manufacturing.
• Strong experience with aseptic filling lines
• In-depth knowledge of GMP, GxP, FDA, and EMA requirements.
• Proven project leadership and stakeholder management skills.
• Fluent English; German is a plus.

Working pattern:
Onsite

Employment type:
Contract

Location:
Germany

Keywords:
CQV Lead | Commissioning & Qualification | Fill Finish | Aseptic Manufacturing | Filling Lines | GMP | Validation | Pharmaceutical Manufacturing

ID: 99493