Process Engineer/Scientist (Biopharma)

Location: Devens, Massachusetts, United States; onsite support at a commercial biopharmaceutical manufacturing facility is required.

Contract duration: 8+ months or 6 months, depending on the assignment, with potential for extension.

Company

hirify.global is a global staffing and IT consulting company providing professionals for client organizations.

What you will do

• Provide technical support for commercial biopharmaceutical manufacturing, process monitoring, technology transfer, and process validation.
• Troubleshoot downstream, cell culture, harvest, filtration, centrifugation, and related bioprocessing operations during scale-up and routine manufacturing.
• Analyze large data sets and process performance results using statistical and modelling methods to recommend process improvements.
• Investigate process deviations, perform root-cause analysis, develop CAPAs, and support change controls.
• Prepare CMC documentation and contribute to regulatory submissions, responses, and inspections.
• Collaborate with Manufacturing, Quality, Engineering, MS&T, and cross-functional teams across multiple sites.

Requirements

• Bachelor’s or master’s degree, or equivalent experience, in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biochemistry, or a related field; an advanced degree is preferred.
• Relevant experience in bioprocess development, validation, or manufacturing support: Ph.D. with 0–2 years, BS/MS with approximately 2–6 years, or BS with 2–4 years for the second assignment.
• Large-scale cell harvest experience and knowledge of cell culture, with capability to provide first-line technical troubleshooting support.
• Experience with process technology transfer, equipment and process validation, biologics manufacturing, and process deviation investigations.
• Working knowledge of SOPs, cGMP requirements, regulatory environments, and biopharmaceutical submissions.
• Strong verbal, written communication, technical writing, project management, and cross-functional collaboration skills; PPE standards apply at the manufacturing site.

Nice to have

• Experience with chromatography, ultrafiltration, depth filtration, facility fit assessments, and scale-up from bench or pilot to production.
• Experience with DOE, SPC, statistical methodologies, biologics manufacturing investigations, or Person-In-Plant start-up support.

Culture & Benefits

• Work in a collaborative, cross-functional, matrix-managed manufacturing environment.
• Contribute to a modern large-scale cell culture facility and commercial manufacturing operations.
• Contract engagement with potential for extension.
• Information is handled confidentially according to EEO guidelines.