Workstream Lead – Automation/CSV

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 – Automation / CSV who will be responsible for the planning, coordination, and execution of automation and Computerized System Validation (CSV) activities within the assigned project scope.

The role covers automation systems, including PLC systems, MES/RDE platforms, local and enterprise-level L3-L5 systems, as well as associated system interfaces, integrations, and data flows supporting GMP manufacturing operations.

Responsibilities include, but are not limited to:

• Define and execute the automation and CSV strategy for systems within the assigned project scope.
• Lead and coordinate Computerized System Validation activities throughout the system lifecycle, from design and implementation through qualification and operational readiness.
• Oversee automation verification activities, including I/O checks, loop checks, functional testing, and system verification activities.
• Coordinate CSV lifecycle deliverables, including validation plans, risk assessments, requirements specifications, test protocols, validation reports, and supporting documentation.
• Manage automation systems integration across PLCs, MES/RDE platforms, local and enterprise L3-L5 systems, and related data interfaces.
• Ensure data flows, system interfaces, and electronic records comply with GMP data integrity requirements.
• Coordinate with process equipment, facilities, utilities, engineering, quality, and manufacturing teams to ensure successful system integration.
• Manage technical dependencies, risks, deviations, and issues impacting the critical path and project delivery.
• Support operational readiness activities, including system handover, user readiness, and transition into GMP operations.
• Ensure compliance with GMP regulations, CSV methodologies, quality standards, and applicable regulatory expectations.

Required Qualifications:

• Bachelor's or Master's degree in Engineering, Computer Science, Automation, Information Technology, or a related technical discipline.
• +5 years of experience in automation engineering, Computerized System Validation (CSV), and qualification activities within GMP pharmaceutical or biopharmaceutical manufacturing environments.
• Proven experience with integrated automation landscapes, including PLC systems, MES/RDE platforms, and L3-L5 automation and enterprise systems.
• Strong understanding of GMP computerized systems, validation lifecycle methodologies, and regulatory expectations.
• Demonstrated experience managing CSV activities, including validation strategy, testing, documentation, and system release.
• Experience with automation verification activities, including I/O checks, loop checks, functional testing, and system integration testing.
• Strong knowledge of GMP data integrity requirements (ALCOA+ principles) and electronic data management practices.
• Experience managing complex system interfaces, data flows, vendors, and multidisciplinary project teams.
• 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.