Process Engineer

Key Responsibilities

• Provide engineering support for a portfolio of manufacturing equipment, facility utilities, laboratory equipment, and support systems
• Serve as a technical subject matter expert for assigned equipment and systems
• Troubleshoot equipment and utility issues, identify root causes, and recommend corrective actions
• Support equipment-related deviation investigations, CAPAs, and change controls
• Provide technical input into preventive maintenance strategies and equipment reliability initiatives
• Identify and implement opportunities for equipment and process improvements
• Participate in engineering projects involving the design, procurement, installation, startup, commissioning, and qualification of new or modified equipment and systems
• Collaborate with Manufacturing, Quality, Validation, Facilities, and other internal stakeholders on equipment-related initiatives
• Support equipment qualification and validation activities
• Prepare and review technical documentation, investigation reports, change controls, protocols, and other engineering documentation
• Ensure activities are performed in accordance with cGMP, SOPs, safety requirements, quality standards, and applicable regulatory expectations
• Support internal and external audits or regulatory inspections as a technical subject matter expert

Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline
• 5-7+ years of professional engineering, facilities, manufacturing, or operations experience
• At least 3 years of experience in a cGMP environment preferred
• Experience supporting GMP manufacturing equipment and/or facility utilities
• Strong troubleshooting and root-cause analysis skills
• Experience with equipment qualification, validation, commissioning, or startup activities
• Familiarity with change controls, deviations, CAPAs, and GMP documentation
• Strong technical writing and documentation skills
• Excellent communication and interpersonal skills
• Ability to work independently while effectively collaborating within a cross-functional team
• Strong attention to detail, flexibility, and initiative