Process Engineer

Job Description

Job Description

Our client is seeking an experienced Process Engineer to support a biopharmaceutical manufacturing facility. This individual will provide engineering support across manufacturing equipment, facility utilities, laboratory systems, and related infrastructure, while also supporting equipment projects, troubleshooting, investigations, and qualification activities.
This is a hands-on engineering role that will work closely with Manufacturing, Quality, Facilities, Validation, and other cross-functional teams. The ideal candidate has experience supporting equipment and utilities in a GMP/cGMP environment and is comfortable serving as a technical subject matter expert.

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
• Work with external vendors, contractors, and equipment suppliers as needed
• 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
• Maintain required training and documentation in a GMP-compliant state

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

Preferred Experience

• Biopharmaceutical, pharmaceutical, or biologics manufacturing experience
• Experience with GMP utilities and manufacturing equipment
• Experience supporting facility or manufacturing expansion projects
• Experience with equipment commissioning and qualification
• Experience working directly with equipment vendors, contractors, and engineering partners
• Experience participating in regulatory inspections or GMP audits
• Master's degree in Engineering or a related technical discipline

Location: Framingham, MA
Schedule: 5 days onsite
Type: Contract opportunity Pandologic. Keywords: Process Engineer, Location: Framingham, MA - 01704 , PL: 604161310