Workstream Lead – Facilities & Utilities

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

Zusammenfassung

PQE Group in Germany is seeking a Workstream Lead – Facilities & Utilities to plan, coordinate, and execute CQV activities for GMP facility systems. You will lead qualification of HVAC, cleanrooms, utilities, and building controls while coordinating with engineering, construction, CQV, operations, and automation teams.

The role requires +5 years CQV experience in pharma/biopharma, a Bachelors or Masters in engineering, and native German with strong English.

Qualifikationen

• Engineering degree required (Bachelor's or Master's).
• Minimum 5 years of CQV/Qualification in GMP pharma/biopharma facilities.
• Strong knowledge of HVAC, cleanrooms, GMP utilities and electrical systems.
• Experience with IV/OV/PQ activities and GMP qualification.
• Proven ability to manage multidisciplinary teams and complex interfaces.
• German native-level proficiency is mandatory; English at least B2.

Aufgaben

• Define and execute CQV strategy for facilities, utilities and controlled environments.
• Lead qualification activities for HVAC, cleanrooms, utilities and electrical systems.
• Plan IV, OV and PQ activities and ensure GMP compliance.
• Coordinate commissioning with engineering, construction, CQV, operations and automation.
• Manage interfaces between facility systems and process equipment needs.
• Review qualification docs, test results, deviations and acceptance criteria.
• Monitor progress, risks and readiness for project delivery.
• Support facility turnover and transition to GMP operations.
• Ensure alignment with GMP regulatory expectations and project quality standards.

Kenntnisse

CQV leadership

GMP knowledge

HVAC systems

Project management

Multidisciplinary teamwork

German language proficiency

English proficiency

Regulatory compliance

Stakeholder management

Ausbildung

Bachelor's or Master's in Engineering

Tools

Building Management System (BMS)

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 – Facilities & Utilities is responsible for the planning, coordination, and execution of CQV activities related to GMP facility systems, utilities, controlled environments, and building infrastructure within the assigned project scope.

The role covers critical facility and utility systems supporting manufacturing operations, including cleanrooms, HVAC systems, process and clean utilities, electrical systems, building management and control systems, and environmental and room monitoring systems.

The Workstream Lead provides technical leadership to ensure that facility and utility systems are qualified, compliant, integrated, and operationally ready to support GMP manufacturing. The role acts as the key interface between engineering, construction, CQV teams, operations, automation, process equipment teams, and other project stakeholders.

Responsibilities include, but are not limited to:

• Define and execute the CQV strategy for facilities, utilities, and controlled environment systems supporting GMP manufacturing.
• Lead qualification activities for HVAC systems, cleanrooms, GMP utilities, electrical systems, building controls, and environmental monitoring systems.
• Plan and oversee Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) activities.
• Ensure facility systems achieve the required GMP conditions, including environmental control parameters, room classifications, monitoring requirements, and utility performance.
• Coordinate commissioning and qualification activities with engineering, construction, vendors, manufacturing, and other workstreams.
• Manage interfaces between facility systems, process equipment requirements, automation systems, and operational needs.
• Review and coordinate qualification documentation, test execution, deviations, and acceptance criteria.
• Monitor workstream progress, risks, dependencies, and readiness status to ensure successful project delivery.
• Support facility turnover, operational readiness, and transition of qualified systems into GMP operations.
• Ensure compliance with GMP requirements, regulatory expectations, and project quality standards.

Required Qualifications:

• Bachelor's or Master's degree in Engineering or a related technical discipline.
• +5 years of experience in CQV, commissioning, and qualification of GMP pharmaceutical or biopharmaceutical facilities.
• Proven experience qualifying facility, utility, and controlled environment systems in bulk manufacturing environments.
• Strong knowledge of HVAC systems, cleanrooms, GMP utilities, electrical systems, building management systems (BMS), and environmental monitoring.
• Demonstrated experience managing Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) activities.
• Strong understanding of GMP facility qualification requirements and regulatory expectations.
• Experience managing multidisciplinary teams, system interfaces, vendors, and complex facility execution activities.
• 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.