Computer Systems Engineer

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from X4 Life Sciences

Client Growth Director at X4 Group | Leadership, Sales Growth

Location: Frankfurt, Germany – Field Based (estimated 3 days per week on site)

A leading global pharmaceutical company is seeking a CSV Lead to support a major capital investment program at their Frankfurt site. This is a long-term contract opportunity for an experienced professional to lead Computer System Validation (CSV) efforts across multiple high-impact projects.

• Team Leadership: Lead and manage the CSV team, ensuring timely delivery of all validation activities.
• Documentation & Planning: Develop CSV master plans, project-specific validation strategies, and all supporting documentation.
• System Oversight: Act as the lead engineer for review and validation of PAS (existing and new), BMS, EMS, Data Historian (OSI Pi), and equipment PLC systems.
• Scope Definition: Identify the full scope of CSV and qualification efforts for both GMP and non-GMP systems.
• Execution Support: Support automation teams in field execution, report writing, and lifecycle documentation.
• Change Control: Lead and coordinate Automation Project Change Control (APCC) processes.
• Vendor Coordination: Manage all CSV vendors through FAT, SAT, and IOQ phases.
• Meetings & Reporting: Run weekly CSV meetings and report progress to the CQV Project Manager.
• Risk Management: Participate in risk assessments including FMEA, PCL, and CIL sessions.
• Template Development: Generate and maintain all automation/CSV project templates.
• Extensive experience leading CSV activities on large-scale pharmaceutical or biopharmaceutical projects.
• Proven track record of delivering projects using a verification/leveraging approach to CSV.
• Strong understanding of GMP compliance and regulatory expectations.
• Experience with complex automation and IT systems in a regulated environment.

If you are an experienced CSV professional ready to take on a leadership role in a dynamic project environment, apply to Lauren Park at X4 Group or connect with Lauren to stay updated on X4 Group’s latest vacancies.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Consulting

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at X4 Life Sciences by 2x

Get notified about new Computer Systems Engineer jobs in Frankfurt, Hesse, Germany.

Jr. Software Developer (w/m/d) Frankfurt

Junior IT Consultant / Software Developer (m/w/d) - (BU2)

Frankfurt am Main, Hesse, Germany 1 year ago

Frankfurt am Main, Hesse, Germany 3 months ago

Backend Junior Software Engineer - Remote 4 days a week (Europe)

Frankfurt, Hesse, Germany $30,000.00-$40,000.00 1 week ago

Frankfurt am Main, Hesse, Germany 6 months ago

Frankfurt am Main, Hesse, Germany 3 months ago

Frankfurt am Main, Hesse, Germany 6 months ago

Frankfurt am Main, Hesse, Germany 1 month ago

IT System-Engineer - Microsoft Solutions (m/w/d)

Frankfurt Rhine-Main Metropolitan Area 5 months ago

System Engineer (all genders) – Microsoft Technologies

(Junior) Software Developer .NET (w/m/d)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.