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.

This role will represent the client's technical, operational, and quality interests with the design firm-ensuring all deliverables align with project objectives, regulatory expectations, and best-in-class aseptic manufacturing practices.

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)

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

To find out more about Real, please visit www.realstaffing.com