Engineer I, MSAT (Biotechnology)

Location: Pittsburgh, PA, United States

Company

hirify.global is a technology-driven biotechnology company providing integrated technologies, services, and manufacturing expertise for advanced therapies from design through commercialization.

What you will do

• Represent MSAT as the technical subject matter expert for drug product manufacturing on cross-functional project teams.
• Support GMP manufacturing, technology transfers, process development, characterization, validation, and continuous improvement projects.
• Work with Process Development, Manufacturing, Supply Chain, Regulatory Sciences, Quality, and external clients on manufacturing process transfers and changes.
• Author and review protocols, technical reports, batch records, SOPs, change controls, deviations, regulatory submissions, and product impact assessments.
• Provide on-call and on-floor technical support, investigate process deviations, perform experiments and data analysis, and develop process improvements.
• Support gap analyses, risk assessments, process performance monitoring, automation evaluations, and site-level MSAT quality system implementation.

Requirements

• BS or MS in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or an equivalent discipline, with 5+ years or 3+ years of relevant experience depending on degree.
• Knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture, process development, validation, and lifecycle management.
• Practical experience with cGMP manufacturing and applicable regulatory requirements.
• Drug manufacturing experience and strong experience leading investigations, writing deviation reports, change controls, and corrective actions.
• Strong technical writing, communication, cross-functional collaboration, data management, and statistical process control skills.
• Ability to stand, walk, bend, stretch, lift 15–20 lbs, and perform physical manufacturing-floor activities while wearing PPE.

Nice to have

• Experience with LOVO, Sepax, Rotea, CliniMACs devices, or automated fillers.
• Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt, or similar certification.

Culture & Benefits

• Regular employment within the MSAT department.
• Work in a highly matrixed, cross-functional environment supporting advanced therapy manufacturing.
• Collaborate with internal functions and external clients on regulated manufacturing programs.