GEA Group
Website:
gea.com
Job details:
Responsibilities / Tasks
The Senior Project Manager – BL Pharma (Separation) manages execution of pharmaceutical separation plants and hygienic/aseptic separation skids, including GEA pharma separators, pump systems, and CIP/SIP‑compatible modules. The role requires strong technical competency in mechanical, electrical, instrumentation, clean utilities, and compliance with pharma validation requirements (IQ/OQ/PQ).
- Execution of Pharma Separation Plants & Pharma-Grade Separation Skids
- Lead execution of pharma separation plants, aseptic separation lines, and sterile utility integration.
- Manage fabrication and delivery of pharma-grade separation skids (aseptic separator skids, CIP/SIP skids, WFI/PS utility integration modules).
- Ensure alignment with GxP, traceability, documentation standards, and validation milestones.
- Develop execution schedules linked to FAT, SAT, IQ/OQ, and commissioning.
- Technical Interpretation & Engineering Coordination
- Interpret PFDs, P&IDs, clean utility diagrams, skid assembly drawings, and piping isometrics.
- Review electrical drawings, wiring diagrams, MCC/VFD integration, control schematics, loop drawings, and instrument hook-ups.
- Ensure design and execution comply with pharma hygienic standards and sterility requirements.
- Customer & Validation Interaction
- Act as primary customer contact for pharma separation execution.
- Conduct technical coordination meetings and manage clarifications.
- Lead FAT, SAT, IQ/OQ execution and documentation support.
- Ensure documentation accuracy: DQ, FAT protocols, SAT reports, IQ/OQ records, and traceability.
- Supplier & Contractor Management
- Coordinate skid fabricators, electrical/automation suppliers, instrumentation vendors, and site erection teams.
- Ensure skid fabrication maintains pharma hygiene and documentation compliance.
- Monitor progress, quality, safety, and adherence to regulatory standards.
- Internal Coordination
- Work with Process Engineering, Automation, CQV, QA/QC, SCM, Manufacturing, and Finance.
- Ensure availability of technical documents, materials, and validation packages.
- Site Execution & Commissioning
- Supervise installation, automation integration, trial runs, and performance testing.
- Ensure sterile conditions, CIP/SIP verification, and compliance with pharma standards.
- Complete documentation and achieve customer acceptance and handover.
Your Profile / Qualifications
- Bachelor’s degree in Mechanical, Electrical, or Industrial Engineering.
- 5–8 years of experience in pharma separation plants, sterile skids, or regulated environments.
- Strong understanding of pharma separators, hygienic valves, pumps, CIP/SIP systems, and aseptic design.
- Excellent ability to interpret PFDs, P&IDs, mechanical/electrical/instrumentation drawings.
- Knowledge of GxP, validation (IQ/OQ/PQ), and documentation processes.
- SAP experience preferred.
- Willingness to travel extensively.
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