Workstream Lead – Cleaning & Media Systems

PQE Group; Hessen; Vor Ort; EUR 68.000 - 83.000; Vollzeit

Benefits dieser Stelle

International projects

Multicultural, collaborative culture

Zusammenfassung

PQE Group is seeking a Workstream Lead for Cleaning & Media Systems in Germany to lead CQV activities related to CIP, cleaning, buffer and media prep, and related process support systems within GMP manufacturing projects.

The role requires extensive CQV experience, strong GMP knowledge, and the ability to manage cross-functional teams in an international project environment. German (C2) and English (B2/C1) proficiency are mandatory, with a starting salary of €75,000.

Qualifikationen

• Bachelor's or Master's degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related technical discipline.
• Extensive CQV, commissioning, qualification, and validation experience in GMP pharma/biopharma facilities.
• Experience with CIP systems, cleaning processes, buffer/media preparation, storage/distribution systems and related equipment.
• Strong understanding of cleaning strategies, contamination control and GMP requirements for cleaning validation and process support systems.
• Experience integrating cleaning/media systems with process equipment, utilities and automation platforms.
• Demonstrated ability to manage qualification activities, system interfaces, dependencies and handover.
• Strong GMP manufacturing process understanding and qualification lifecycle knowledge.
• Experience coordinating multidisciplinary teams and managing complex technical interfaces.
• Fluent German (C2) and professional English (B2/C1).
• Salary starts at 75,000€.

Aufgaben

• 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 proper testing, qualification and readiness for GMP manufacturing operations.
• Develop and oversee qualification approaches considering cleaning strategies, contamination control and process integration needs.
• Ensure effective integration between cleaning systems, process equipment, utilities, automation and manufacturing operations.
• Manage interfaces and dependencies between cleaning/media systems and other project workstreams.
• Coordinate qualification execution activities including protocol development, testing, issue resolution, deviation management and document review.
• Ensure cleaning processes support contamination control strategies and GMP expectations.
• Oversee system readiness, turnover activities and handover to operations.
• Identify and manage technical risks, constraints and cross-functional dependencies impacting delivery.
• Coordinate multidisciplinary teams, vendors and stakeholders to ensure timely CQV milestones.

Kenntnisse

CQV Experience

GMP knowledge

Qualification lifecycle

Contamination control

Cross-functional leadership

Stakeholder management

International project environment

German language (C2)

English language (B2/C1)

Ausbildung

Bachelor's or Master's degree in Engineering or related technical discipline

Tools

CIP systems

Cleaning validation

Process integration platforms

Jobbeschreibung

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 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€

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.