Director, Process Engineering (Peptides)

Responsibilities

• Lead a team of Subject matter experts to drive engineering schedules of selected A&E consultants
• Serve as the owner’s senior process engineering leader for major capital projects
• Provide leadership to the owner’s process engineering team and coordinate with contractor engineering organizations
• Establish process engineering execution strategies and technical standards for the project
• Ensure alignment of process designs with manufacturing requirements, regulatory expectations, and corporate engineering standards
• Drive cross-functional integration between engineering, operations, quality, and PDS&T teams
• Act as the Process Engineering Design Authority, responsible for technical approval and governance of key process engineering deliverables
• Provide oversight and approval of critical engineering documents including Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), Process schematics and system architecture, Cause and Effect diagrams, control narratives and operations philosophy documentation
• Lead multidisciplinary design reviews to ensure completeness, operability, and compliance with project standards
• Support corporate capital project governance and stage-gate review processes
• Ensure process engineering deliverables are completed to required maturity levels at each project phase
• Define and oversee process system architecture, system boundaries, and equipment integration
• Ensure process systems are effectively integrated with Utility systems, Automation and control systems, Facility infrastructure, Cleanroom and environmental systems
• Provide technical oversight for development and verification of process fluid lists and line lists
• Ensure proper classification of process streams and evaluate material compatibility, corrosion risks, and contamination risks associated with process fluids
• Ensure alignment between process fluid characteristics and material selection for piping, valves, and equipment
• Lead development and approval of operations philosophy documentation defining system operation, control strategies, and operational boundaries
• Ensure process systems support safe startup, shutdown, maintenance, and cleaning activities
• Integrate operational considerations into design including human factors, accessibility, and maintainability
• Collaborate with operations and MSAT teams to ensure long-term operability of process systems
• Support systemization and turnover to CQV teams by providing technical support during system startup and operational readiness activities
• Lead resolution of process engineering issues identified during commissioning and qualification
• Monitor contractor performance, deliverables quality, and resource utilization
• Ensure efficient coordination between contractor teams and internal engineering resources
• Oversee engineering budgets and resource plans across the project lifecycle
• Identify and mitigate risks that could impact project cost or timeline

Qualifications

• BS, Engineering or equivalent technical degree; Master’s degree in Engineering or MBA preferred
• 20+ years of experience as a Senior Engineering / Projects / Operations Leader across multiple technologies
• Proven leadership experience in engineering of mega-capital projects ($500MM – $1B+)
• Deep knowledge of engineering systems in all disciplines in biopharmaceutical industry
• Proven inclusive management and leadership capabilities of large cross-functional teams and the ability to effectively interact and communicate with senior leadership and executives from strategic partners and authorities
• Demonstrated experience managing Engineering contractors and global equipment vendors
• Results-oriented leadership with outstanding negotiation skills and risk-based decision making is required

Key Stakeholders

• ME&C
• PDS&T
• R&D
• Procurement
• Global Engineering
• EHS
• Facilities
• AI and Digital Transformation
• Government Affairs
• External agencies including vendors, contractors, government agencies.