About

• Overview

• PM Group is seeking a Senior Process Engineer to join our Outsourced Technical Services (OTS) group, supporting capital delivery programs for leading pharmaceutical and biotechnology clients. This role will act as the Process Work Package Owner, responsible for end-to-end ownership of GMP process systems from conceptual and detailed design through commissioning, qualification, and validation (CQV). The focus of this role will be on Fill / Finish equipment.
• The successful candidate will provide process design leadership, technical governance, and cross-functional coordination across engineering, construction, CQV, and manufacturing stakeholders to ensure safe, compliant, and operable GMP process systems. This position suits an engineer who thrives in complex, fast-paced project environments and is comfortable owning technically challenging work packages with minimal oversight.

• Responsibilities

• Process Design & Engineering Leadership
• · Serve as Process Work Package Owner for GMP manufacturing process systems on capital projects.
• · Lead process design activities across project phases, including conceptual design, basic design, detailed design, and design for CQV readiness.
• · Develop and review process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), equipment specifications, datasheets, and design narratives.
• · Ensure process designs meet GMP, safety, operability, maintainability, and lifecycle requirements.
• Project Delivery & Cross-Functional Coordination
• · Act as technical lead for assigned process systems, coordinating closely with Facilities, MS&T, Automation, Validation, CQV, and Equipment End Users.
• · Drive execution of medium to large-scale process work packages with complex scope, aggressive schedules, and high compliance expectations.
• · Provide technical oversight during equipment procurement, FAT/SAT support, construction, installation, and startup activities.
• · Support design change management and field-driven modifications during construction and commissioning.
• CQV & Lifecycle Ownership
• · Own the process scope through CQV, ensuring design intent is effectively translated into commissioning and qualification activities.
• · Partner with CQV teams to support commissioning strategies, system boundaries, risk assessments, and qualification documentation.
• · Ensure smooth engineering turnover to CQV and operations, maintaining complete and compliant documentation packages.
• · Support start-up and operational readiness, including system troubleshooting and performance optimization.
• Technical SME & Problem Solving

· Provide Subject Matter Expertise (SME) for GMP process equipment, including but not limited to

• o Fill / Finish Equipment
• · Lead structured root cause investigations for equipment or process issues, independently driving resolution.
• · Own or support Change Controls, Deviations, and CAPAs related to process systems.
• · Contribute to preventative maintenance strategies and continuous improvement initiatives.
• Documentation & Quality
• · Produce and review high-quality technical documentation in accordance with client quality systems and PM Group standards.
• · Maintain Engineering Turnover Packages (ETOPs), including specifications, component lists, vendor documentation, drawings, and manuals.
• · Ensure documentation supports both regulatory compliance and operational sustainability.

• Qualifications

• · Bachelor’s degree in Chemical Engineering or Mechanical Engineering (or equivalent).
• · 7+ years of relevant experience in GMP process engineering within pharmaceutical or biotechnology environments.
• · Demonstrated experience acting as a process system owner or work package owner on capital projects.
• · Strong background in process design, equipment specification, and lifecycle project delivery.
• · Experience supporting projects through CQV and operational handover
• All of your information is confidential according to EEO guidelines.
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