Process Engineer

We are seeking a Process Engineer to provide specialist technical support for bioprocess systems as part of a major capital investment project. This role is focused on process design, system implementation, and lifecycle support to ensure operational readiness, safety, and compliance with industry standards.

Key Responsibilities:

• Develop User Requirement Specifications (URS) for designated systems.
• Review and sign off on Basis of Design (BOD), detailed engineering deliverables, and key process documentation such as PFDs and P&IDs.
• Ensure all procurement documentation (e.g., BOMs, datasheets, technical cut-sheets) aligns with internal equipment standards.
• Monitor and close out HAZOP-related actions, integrating outcomes into design deliverables.
• Participate in design model reviews (30%, 60%, 90%) to validate that systems are safe, practical, and fit for purpose.
• Approve and maintain system lifecycle documentation, including Functional Specifications (FS), Software Design Specifications (SDS), and IO lists.
• Support and attend Factory Acceptance Testing (FAT) and software bench testing when required.
• Lead and oversee Site Acceptance Testing (SAT), commissioning, and qualification activities.
• Draft and execute FAT, SAT, and commissioning protocols, ensuring adherence to internal specifications.
• Validate and maintain vendor documentation to meet internal standards.
• Create Preventive Maintenance (PM) plans and establish spare parts requirements using the Computerized Maintenance Management System (CMMS).

Qualifications and Experience:

• Bachelor's degree in Chemical, Process, or Mechanical Engineering (or equivalent) with 3-5 years of relevant industry experience. Equivalent practical experience may be considered in lieu of formal education.
• Previous exposure to biopharmaceutical manufacturing or process equipment is strongly preferred.
• Background in process design, commissioning, and validation within regulated industries is highly desirable.
• Familiarity with DeltaV distributed control systems is a plus.