Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.
Due to our continuous growth, PQE Group is seeking a Workstream Lead – Cleaning & Media Systems who will be responsible for the planning, coordination, and execution of CQV activities related to cleaning systems, CIP (Clean-in-Place) systems, buffer and media preparation systems, storage and distribution systems, and associated process support systems within the assigned project scope.
The role provides technical leadership for the qualification and operational readiness of cleaning and media systems, ensuring that systems are effectively integrated with process equipment and utilities to support compliant GMP manufacturing operations.
Responsibilities include, but are not limited to:
- Define and execute the CQV strategy for CIP, cleaning, buffer preparation, media preparation, storage, distribution, and related process support systems.
- Lead qualification activities for cleaning and media systems, ensuring systems are properly tested, qualified, and ready for GMP manufacturing operations.
- Develop and oversee qualification approaches considering cleaning strategies, contamination control requirements, and process integration needs.
- Ensure effective integration between cleaning systems, process equipment, utilities, automation, and manufacturing operations.
- Manage interfaces and dependencies between cleaning and media systems and other project workstreams.
- Coordinate qualification execution activities, including protocol development, testing, issue resolution, deviation management, and documentation review.
- Ensure cleaning processes support contamination control strategies and meet GMP expectations.
- Oversee system readiness, turnover activities, and handover of qualified systems to operations.
- Identify and manage technical risks, execution constraints, and cross-functional dependencies impacting project delivery.
- Coordinate multidisciplinary teams, vendors, and stakeholders to ensure timely completion of CQV milestones.
Required Qualifications:
- Bachelor's or Master's degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related technical discipline.
- Extensive experience in CQV, commissioning, qualification, and validation activities within GMP pharmaceutical or biopharmaceutical manufacturing facilities.
- Proven experience with CIP systems, cleaning processes, buffer and media preparation systems, storage and distribution systems, and associated process support equipment.
- Strong understanding of cleaning strategies, contamination control principles, and GMP requirements for cleaning validation and process support systems.
- Experience integrating cleaning and media systems with process equipment, utilities, and automation platforms.
- Demonstrated experience managing qualification activities, system interfaces, dependencies, and operational handover activities.
- Strong understanding of GMP manufacturing processes and qualification lifecycle methodologies.
- Experience coordinating multidisciplinary teams and managing complex technical interfaces.
- Strong organizational, communication, and stakeholder management skills.
- Ability to work effectively in an international project environment.
- Native-level proficiency in German (C2 or equivalent) is mandatory, professional proficiency in English (minimum B2, preferably C1) is required.
- Salary starts since 75.000€
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.