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).
1. 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.
2. 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.
3. 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.
4. 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.
5. Internal Coordination
Work with Process Engineering, Automation, CQV, QA/QC, SCM, Manufacturing, and Finance.
Ensure availability of technical documents, materials, and validation packages.
6. 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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