1. Technical Package Development
• Review and understand the current facility design, URS, process flow, and utility requirements.
• Develop comprehensive technical RFP packages including:
• Review and update of User Requirements Specifications (URS)
• Process & Instrumentation alignment (P&IDs) including PHA/HAZOP.
• Functional descriptions
• Technical evaluation criteria
• Implementation of GMP and containment requirements (e.g., OEB/OEL, closed handling, CIP/WIP)
• Implementation of ATEX requirements
• Coordinate internal SMEs (process, CQV, EHS, validation, QA) to ensure requirements are incorporated.
2. Vendor Selection & Procurement
• Run the full RFP and vendor selection process, including:
• Bid solicitation, vendor Q&A management
• Technical and commercial bid evaluations
• Vendor capability assessments and reference checks
• Leadership of decision making forums and recommendation reports
• Negotiate scope, deliverables, and timelines with selected vendors in coordination with procurement.
3. Package Ownership
• Responsible for the supply, install and start-up of equipment packages (e.g., reactors, chromatography systems, high containment isolators, solvent systems, ancillary utilities, etc.). Supervise a team of package owners who will be the primary contacts for the major packages.
• Manage vendor progress through:
• Design reviews (DQ) and including coordination with the facility scope to ensure installation, operability, maintainability.
• Factory build oversight
• FAT preparation and execution
• Track issues, risks, and deliverables; ensure timely resolution.
4. FAT, Commissioning & Qualification
• Technical issue resolution and integration: Work closely with Engineering, Procurement, and Commissioning/CQV teams to resolve technical issues rapidly, maintain package progress, and ensure prerequisites for commissioning/CQV are met (including “Safe to Start” controls, energization readiness and PSSR).
• Quality control, inspection, and turnover: Enforce the construction quality requirements; ensure robust ITPs (Inspection and Test Plans), in process inspections/testing, and approval of mock ups/samples; drive accurate as built documentation and CTOD (Construction Turnover Documentation); lead readiness for MC (Mechanical Completion) walkdowns, verification of records, and punchlist management to mechanical completion.
• Provide input on C&Q strategy and approach (risk based, ASTM E2500) and IQ/OQ test plans
• Develop FAT protocols and coordinate execution with equipment vendors.
• Ensure smooth transition from vendor FAT → site receipt → installation → CQV.
• Supervise vendor SAT & subsequent testing, support CQV team in IQ/OQ execution.
5. Project Leadership & Governance
• Lead a team of technical package leads to ensure the proper design, fabrication, delivery and testing of equipment within the required timeline and cost.
• Maintain detailed schedule, risks, and milestones for all assigned systems.
• Provide clear weekly reporting on progress, issues, and mitigation plans.
• Facilitate cross functional meetings between engineering, procurement, CQV, operations, EHS, and QA.
