Process Engineer

Job Description

Job Description Insight Global is seeking a Process Engineer II to support a growing radiopharmaceutical manufacturing operation in Billerica, Massachusetts. This individual will focus on sustaining and managing the lifecycle of an existing product portfolio while helping ensure products remain stable, available, and consistently manufactured over time. The Process Engineer II will drive product and process changes, execute change orders, support validations and part qualifications, and troubleshoot technical issues within a highly regulated cleanroom manufacturing environment. The position will work cross-functionally with Manufacturing, Quality, Engineering, Supply Chain, and other stakeholders to maintain product continuity and resolve product-focused deviations and investigations. The ideal candidate has experience supporting biopharmaceutical or medical device manufacturing and understands what it takes to execute changes in a regulated environment. Experience with sterile manufacturing, radiopharmaceuticals, validation, equipment qualification, or radioactive materials would be highly valuable. Day-to-Day Responsibilities

• Drive product changes and engineering change orders supporting the existing product portfolio.
• Help maintain product and lifecycle stability so products can be manufactured consistently now and in the future.
• Lead or support product-focused deviations, investigations, root cause analyses, and corrective actions.
• Support process validations, equipment qualifications, part qualifications, and risk assessments.
• Evaluate the impact of proposed changes and develop appropriate implementation plans.
• Author and revise manufacturing documentation, technical reports, validation protocols, qualification documents, and controlled procedures.
• Provide technical troubleshooting and day-to-day engineering support for manufacturing operations.
• Monitor process performance and analyze manufacturing data to identify trends and improvement opportunities.
• Support technical transfers, process improvements, equipment upgrades, and lifecycle initiatives.
• Partner with Manufacturing, QA, QC, Engineering, and Supply Chain to implement compliant solutions.
• Manage projects from initial problem identification through implementation, validation, and final delivery. Support internal audits, regulatory inspections, and documentation-readiness activities.

Skills and Requirements

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Nuclear Engineering, Chemistry, or a related technical discipline.

• Experience working in biopharmaceutical or medical device manufacturing.

• Experience supporting manufacturing in a regulated, cGMP, cleanroom, or controlled production environment.

• Strong problem-solving and root cause analysis skills.

• Experience investigating product or process deviations and implementing solutions.

• Experience supporting engineering change orders, change controls, validations, qualifications, or comparable quality-system activities.

• Ability to work effectively across Manufacturing, Quality, Engineering, Supply Chain, and other functional teams.

• Strong written and verbal communication skills.

• Ability to take ownership of a problem and help drive the solution through completion. Ability to work onsite in Billerica five days per week.

• Experience in radiopharmaceutical or radioactive-material manufacturing.

• Experience supporting sterile injectable, aseptic, or fill-finish operations.

• Strong project management experience, including ownership of project scope, deliverables, risks, and timelines.

• Experience managing the lifecycle of commercially approved pharmaceutical or medical device products.

• Experience leading cross-functional projects within a matrixed organization.

• Familiarity with CAPA, IQ/OQ/PQ, process validation, equipment qualification, risk assessments, or technical transfers.

• Experience with TrackWise, CATSWeb, or another electronic document or change-control system.

• Experience with Lean manufacturing or continuous-improvement initiatives. Proficiency with Excel and manufacturing data analysis.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].