Program Integration & Technical Oversight Lead

Responsibilities

• Review and challenge equipment/vendor packages, architectural layouts, and MEP/structural designs to confirm fitness for purpose, operability, maintainability, and compliance.
• Confirm spatial coordination and clashes resolution for equipment envelopes, pits/plinths, pipe/electrical/IT pathways, penetrations, and access/maintenance clearances.
• Lead the planning and execution of the commissioning and qualification plan for Lab equipment.
• Work with the Asset Management team in the development of the CQV schedule and execution strategy; identify synergies, define sequencing of installation and start-up of equipment in accordance with users’ needs.
• Leverage vendor FAT/SAT and integrated systems testing to define system boundaries, critical aspects, and traceability from user requirements specifications to test evidence; manage turnover from construction to commissioning to IOQ and performance readiness.
• Cook up the coordination and support manufacturing and quality and change control compliance.
• Startup readiness and handover: partner with area owners to provide support on Owner’s operational readiness: SOPs, training, spare parts/consumables, maintenance plans, alarms/limits, and contingency plans for first runs.
• Asset Management vendor turn over documents for completeness and right-first-time quality: as-builts, O&M manuals, calibration certificates, pre-commissioning/commissioning records, TAB reports, and vendor dossiers.
• Ensure compliance with relevant building and safety codes and standards (e.g., cleanroom and HVAC practices, electrical/life safety requirements).
• Stakeholder management and reporting, interfacing with construction managers, manufacturers, A/E firms, IT, Quality, EHS, and all other stakeholders to align milestones and deliverables.
• Track progress and risks via dashboards and KPIs; report status and mitigations to project leadership.

Requirements

• Bachelor’s degree or Master’s in Chemical/Biochemical/Mechanical Engineering or related discipline.
• Large-scale biopharma R&D projects with complex interfaces.
• 10 years in large scale biopharma facilities with significant construction site and startup exposure, spanning commissioning, qualification, validation, or field engineering.
• Proficiency interpreting architectural/MEP/structural drawings; electrical one-lines; controls narratives; cleanroom zoning and pressure schematics.
• Demonstrated leadership of FAT/SAT, pre-functional checks, commissioning, IOQ, TAB, and integrated building systems startup (BMS/EMS, HVAC, electrical, fire/life safety).
• Experience resolving RFIs, NCRs, and field changes; familiarity with QA/QC, ITPs, and turnover workflows.
• Working knowledge of clean and black utilities (clean steam, process gases, HVAC for R&D facilities); contamination control, sterilization and automation integration.