Process Engineer II

About the role

The Process Engineer II will support the design, specification, procurement, installation, start‑up and commissioning of manufacturing equipment, facility areas and process utility systems. The role involves managing projects from scope definition through cost control and documentation, while ensuring compliance with GMP, quality and regulatory requirements.

Key responsibilities

• Develop specifications, procure and install new manufacturing equipment and utility systems.
• Lead start‑up, commissioning and IQ/OQ activities and prepare final documentation.
• Define project scope, estimate costs, manage budgets and initiate capital requests.
• Conduct studies and recommend new technologies, tools and practices to improve site effectiveness.
• Prepare and review engineering documents such as SOPs, protocols, reports, schedules and vendor drawings.
• Ensure designs comply with company policies, local, state and federal regulations.
• Provide direction to engineering support staff and collaborate across functional teams.
• Analyze data, generate reports, charts and graphs to support project recommendations.

Required profile

• Bachelor of Science in Engineering or equivalent education and experience.
• Minimum two years of experience in GMP manufacturing environments.
• Demonstrated ability to work independently and apply engineering judgment.
• Experience managing engineering projects and supporting documentation.

Required skills

• Equipment specification, procurement, installation and commissioning.
• Project scope definition, cost estimation and budget management.
• IQ/OQ testing and validation.
• GMP manufacturing practices.
• Process utilities system design.
• Regulatory compliance and documentation.
• Data analysis and technical report preparation.