MSAT Process Engineer/Scientist III (Downstream)

Location: On-site in Portsmouth, New Hampshire, United States

Company

hirify.global is a life sciences manufacturing company with more than 30 sites across five continents, producing medicines through globally connected teams.

What you will do

• Provide primary technical support for mammalian manufacturing processes, including process transfer, process understanding, gap analysis, FMEA, process modeling, and process monitoring.
• Author and review process descriptions, definitive formulations, batch records, raw material listings, change controls, planned deviations, and campaign summary reports.
• Assess major deviations, investigate potential root causes, identify solutions, and evaluate the impact of process, equipment, and procedural changes on product quality.
• Perform and interpret complex data analyses, including multiple linear regression, ANOVA, and multivariate analysis.
• Support lot release, regulatory documentation, customer technical interactions, internal project teams, and customer and regulatory audits.
• Provide guidance to junior team members and participate in deviation and daily manufacturing management meetings.

Requirements

• Bachelor’s degree in Biotechnology, Biological Sciences, or Chemical Engineering.
• At least 5 years of biotech industry experience, or 3+ years with a master’s degree or 2+ years with a PhD, including process development and process scale-up or manufacturing.
• Experience supporting large-scale manufacturing, preferably mammalian processes, with knowledge of current Good Manufacturing Practices and US/EU regulations.
• Advanced knowledge of cell biology, cell culture, scale-up, mass transfer, bioreactor operation, disc-stack centrifugation, and filtration.
• Intermediate knowledge of statistical data analysis and experience with structured problem-solving tools such as Fishbone and Kepner-Tregoe.
• Willingness to provide 24/7 on-call support during manufacturing.

Culture & Benefits

• Competitive salary and comprehensive benefits package.
• Career development and advancement opportunities.
• Supportive, collaborative, and inclusive workplace culture.
• Access to advanced technology and tools.
• Commitment to employee well-being, safety, and recognition of contributions.