Director, Process Engineering (Peptides)

Purpose

The Director of Process Engineering will lead the process engineering effort for multiple strategic projects. This role serves as the owner-side Design Authority for process engineering on major biopharmaceutical capital programs. This role provides strategic leadership, technical governance, and oversight of all process engineering activities supporting large-scale manufacturing facility projects. The incumbent is responsible for ensuring that process systems are designed, integrated, and implemented in alignment with corporate engineering standards, regulatory expectations, and operational requirements. The role provides technical oversight of A&E contractor engineering activities and ensures that core process engineering deliverables—including process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), cause and effect diagrams, process schematics, and operations philosophy documentation—meet the technical, safety, and operational standards required for pharmaceutical manufacturing facilities. As part of the project leadership team, the Director ensures effective integration of process design with utilities, automation, commissioning, qualification, and operational readiness activities. The role also supports corporate capital governance stage-gate processes, process safety management, and technology transfer integration with PDS&T, when required. The incumbent will report to Director, Engineering in the Operations Transformation organization.

Responsibilities

• Lead a team of Subject matter experts to drive engineering schedules of selected A&E consultants
• Ensure deliverables are reviewed, approved and issued for design or construction to ensure that the project procurement and construction activities proceed without any interruption
• 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.
• Ensure design consistency across engineering disciplines including process, mechanical, utilities, automation, and facility systems.
• 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.
• Provide governance and technical review for process piping design including Pipe sizing and hydraulic calculations, Pressure drop and flow rate analysis, Line classification and specifications
• Ensure piping designs support process reliability, cleanability, maintainability, and sterility where applicable.
• Ensure process systems meet corporate and regulatory process safety management (PSM) requirements including
• Provide oversight for process safety analyses including Relief valve sizing calculations, Overpressure protection analysis, Process hazard analysis (PHA), HAZOP facilitation and resolution
• Review safety-critical calculations and engineering analyses.
• 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.
• Ensure efficient utilization of both internal and contractor engineering resources.
• Support development of capital cost estimates and engineering schedules.
• Identify and mitigate risks that could impact project cost or timeline.
• Contribute to and lead a high-performing project organization including program managers, engineering leads, construction managers, CQV leads, and project controls professionals.
• Foster a culture of safety, accountability, collaboration, and operational excellence.
  
  

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
• Ability to mentor and develop next generation of leaders
• Travel within the US outside the US for reviews/workshops/visits to vendor facilities will be 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.