Consultant, Program Integration & Technical Oversight Lead, Construction Summary Our client, a global Fortune 500 medical device company, has engaged GForce to provide a Program Integration & Technical Oversight Lead (PITOL) serves as the Owner’s technical steward across late design review, construction, installation, commissioning, qualification, testing, and startup for a large-scale biopharmaceutical R&D project. This person will verify that equipment and building systems are correctly designed and specified, ensure the facility is constructed to support process requirements, and lead a compliant, efficient transition from construction to routine R&D operations. The PITOL shall ensure that process equipment, building infrastructure, and utilities are specified, built, installed, commissioned, qualified, tested, and started up on schedule and in compliance with regulations and applicable codes—achieving operability, maintainability, and performance targets while resolving technical issues in the field with exemplary safety performance during construction and startup. This role ensures the building and its systems are constructed to enable the process to perform as intended. This person will safeguard user needs, drive efficient field execution, resolve construction issues decisively, and deliver a facility that is audit-ready from day one.
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.
Verify building requirements for equipment function: room classifications, pressure cascades, HVAC capacity and control, environmental monitoring provisions, vibration/noise limits, ceiling heights, loads and supports, seismic anchorage, floor flatness/levelness, slopes and drains, electrical power quality and redundancy, earthing, cleanroom finishes, door interlocks, pass-throughs, material/personnel flows, and zoning.
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; identifying synergies, define sequencing of installation and start-up of equipment in accordance with users’ needs.
Oversee the risk-based commissioning, qualification, and validation (CQV) strategy and plans, leveraging vendor FAT/SAT and integrated systems testing.
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.
Coordinate execution and support manufacturing and quality and change control compliance.
Startup readiness and handover: partners 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.
Compliance; achievement of environmental and process performance targets (capacity, quality, reliability) at release to operations.
Ensure adherence to 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.
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.