Senior/Principal Process Engineer

Role Overview

We are seeking an experienced Process Package Owner (PPO) to act as the Owner’s Representative and Engineer of Record for aseptic fill/finish systems during early-phase concept and design development.

Key Responsibilities

Design Representation & Oversight

- Serve as the primary technical liaison between the client and engineering/design partners - Represent the client in design reviews, workshops, and technical discussions - Critically review design deliverables to ensure alignment with client standards, URS, and industry best practices - Provide clear, timely, and actionable feedback to design teams - Drive balanced decisions across cost, schedule, quality, and compliance

Engineering & Documentation Leadership

- Review and approve key design documents, including: - Process Flow Diagrams (PFDs) - Piping & Instrumentation Diagrams (P&IDs) - Equipment layouts and facility arrangements - Lead and support development of User Requirements Specifications (URS) - Ensure designs incorporate: - Aseptic processing principles - Contamination Control Strategies (CCS) - Regulatory requirements (FDA, EU Annex 1, etc.) - Act as Engineer of Record for assigned process packages

Process & Equipment Ownership

Provide subject matter expertise and technical ownership for: - Vial filling and capping systems - Syringe filling and closing systems (including nested formats) - Supporting equipment: - Debaggers - E-beam sterilization systems - Isolators (filling and material transfer) - Autoclaves - Inspection and testing systems: - Container Closure Integrity Testing (CCIT) - Visual inspection lines

Integration & Cross-Functional Coordination

- Ensure seamless integration across upstream/downstream systems and utilities - Collaborate with process, automation, facilities, and QA teams for cohesive system design - Identify and mitigate design risks early in the project lifecycle - Support technology selection and vendor alignment

Quality, Compliance & Risk Management

- Ensure designs support aseptic assurance, sterility, and regulatory compliance - Promote best practices in cleanability, sterilization, and environmental control - Support development of contamination control strategies and risk assessments (e.g., FMEA)