Process Engineer

Contract position based in Norwood, MA.

About the role

Reduce manufacturing events, user interventions, and batch record excursions by ensuring optimal functionality of equipment and machinery such as Ultrafiltration, Chromatography, Mix Skid, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, CIP, Aseptic Filling Lines, Isolators, Visual Inspection Machines, Packaging Lines, Formulation Equipment, Analytical Equipment, and Component Prep Equipment.

Responsibilities

• Drive results by owning and completing medium to large-sized projects with challenging timelines and minimal support from management.
• Participate in all phases of engineering projects related to processing equipment, including design, equipment procurement, asset induction, construction, installation, start-up, commissioning, validation, and qualification of facilities and/or equipment.
• Respond to alarms, Out of Specification Conditions, and Out of Tolerances and ensure product impact assessments are performed as necessary.
• Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, own Corrective/Preventative Actions and associated Change Controls.
• Own and maintain process equipment assets through CMMS (preventative maintenance plans, calibration data sheets, spare parts, work order workflows).
• Own quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment.
• Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment.
• Develop and implement updates for automated methods of processing equipment, ensuring seamless integration and minimal disruption to ongoing operations.
• Provide guidance and training on new processes, equipment, and troubleshooting techniques.
• Work closely with the Quality Assurance team to ensure all manufacturing processes meet internal and external regulatory requirements, supporting deviation initiation, CAPAs, and out-of-tolerance investigations.
• Ensure all manufacturing activities comply with health, safety, and environmental regulations.
• Assist in the setup/changeover of manufacturing systems and processes.
• Participate in internal and external audits, addressing any findings, and implementing any corrective actions.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

Requirements

• BS or M.S. in a life science.
• Minimum 5 years relevant experience in Facilities, Engineering, or Operations.
• Must be able to use technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions.
• Experience evaluating production line performance such as OEE, reliability performance metrics such as MTBF and MTTF, and life cycle management.
• Familiarity with Microsoft Office Suite is required; basic statistical analysis techniques are preferred.

Pay

$48.00 - $57.00/hr.

Benefits

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may include:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

This is a fully onsite, contract position in Norwood, MA.