Workstream Lead - Process Equipment

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

Zusammenfassung

PQE Group is seeking a Workstream Lead – Process Equipment to drive CQV activities across GMP process equipment, guiding qualification strategy and cross-functional coordination for complex systems in pharmaceutical manufacturing.

The role interfaces with process engineering, vendors, CQV teams and manufacturing, ensuring compliant delivery and handover of qualified equipment, with German (C2) and English (B2/C1) proficiency and a minimum salary starting at 75,000€.

Qualifikationen

• Bachelor's or Master's degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related technical field.
• Extensive CQV, commissioning, qualification and validation experience for GMP process equipment in pharma/biopharma.
• Experience qualifying complex equipment packages and executing OQ activities.

Aufgaben

• Define and execute CQV strategy for process equipment across manufacturing areas.
• Lead qualification activities for chromatography, filtration, virus inactivation, UF/DF, and bulk API equipment.
• Develop and oversee OQ execution and end-to-end process verification.
• Coordinate qualification activities, including protocol execution and documentation review.
• Manage interfaces between equipment, automation, utilities, facilities, and manufacturing.
• Ensure compliance with GMP and readiness for handover to production.
• Identify risks, deviations and constraints affecting delivery.
• Coordinate cross-functional teams and vendors to meet milestones.
• Support operational readiness and transition of qualified equipment into production.

Kenntnisse

Analytical skills

Organizational skills

Problem solving

Communication skills

English proficiency

German proficiency

International collaboration

Ausbildung

Bachelor's or Master's in Engineering/Biotech/Pharma

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 – Process Equipment who will be responsible for the planning, coordination, and execution of CQV activities related to GMP process equipment across the complete process chain, including Pre-Virus, Post-Virus, Final Bulk, and associated process systems. The role also covers stand-alone and ancillary process equipment not assigned to other workstreams.

The Workstream Lead provides technical leadership for process equipment qualification activities, ensuring that equipment packages are properly integrated, qualified, and ready to support manufacturing operations. The role acts as the key interface between process engineering, equipment vendors, CQV teams, manufacturing, automation, and other project stakeholders.

The Workstream Lead is accountable for defining the execution approach, managing equipment interfaces and dependencies, and ensuring successful delivery of qualification activities in accordance with GMP requirements, project timelines, and quality standards.

Responsibilities include, but are not limited to:

• Define and execute the CQV strategy for process equipment across the assigned manufacturing process areas.
• Lead qualification activities for complex process equipment packages, including chromatography systems, filtration systems, virus inactivation systems, UF/DF systems, and bulk API manufacturing equipment.
• Develop and oversee the execution strategy for Operational Qualification (OQ) activities and end-to-end process verification.
• Coordinate equipment qualification activities, including protocol execution, test coordination, issue resolution, and qualification documentation review.
• Manage interfaces between process equipment, automation, utilities, facilities, and manufacturing operations.
• Ensure process equipment meets operational, performance, and GMP requirements before handover to manufacturing.
• Identify and manage technical risks, dependencies, deviations, and execution constraints impacting delivery.
• Coordinate cross-functional teams and equipment suppliers to ensure timely completion of qualification milestones.
• Support operational readiness activities and successful transition of qualified equipment into production.

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 of GMP process equipment within pharmaceutical or biopharmaceutical manufacturing facilities.
• Proven technical expertise in chromatography, filtration, virus inactivation, ultrafiltration/diafiltration (UF/DF), and bulk API manufacturing processes.
• Demonstrated experience qualifying complex equipment packages and executing OQ activities.
• Strong understanding of GMP requirements, validation principles, and qualification lifecycle.
• Experience managing equipment interfaces, vendors, multidisciplinary teams, and complex project execution activities.
• Strong analytical, organizational, and problem-solving skills.
• Excellent communication skills and ability to operate 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.