MS&T Engineer

MissionHires is seeking an MS&T Engineer on behalf of a fast-growing online pharmacy company to provide technical support for commercial pharmaceutical manufacturing in an FDA-regulated environment. This role will lead and support technology transfers, process characterization, scale-up, troubleshooting, and lifecycle improvement initiatives while partnering closely with Manufacturing, Quality, Regulatory Affairs, and Development teams to maintain robust, compliant, and efficient processes.

• Execute and support technology transfer activities for new or modified manufacturing processes, ensuring a smooth transition from development to commercial operations.
• Design, plan, and execute process characterization and scale-up studies, including statistical analysis such as Design of Experiments (DoE) and multivariate analysis.
• Author engineering protocols, technical reports, and supporting documentation in compliance with GMP and applicable FDA, EMA, and ICH requirements.
• Support deviation investigations, root cause analyses, and implementation of corrective and preventive actions (CAPAs) related to process issues.
• Provide technical input for regulatory filings, including IND, NDA, BLA, and post-approval changes, and support responses to regulatory questions.
• Assist with or lead cross-functional projects involving technology transfer, process optimization, validation, and product lifecycle initiatives.
• Develop and maintain project timelines, risk assessments, deliverables, and action plans in partnership with Quality, Manufacturing, Regulatory Affairs, and Development teams.
• Organize and lead technical meetings, track action items, and drive timely completion of commitments.
• Prepare project updates and communicate technical progress, risks, and outcomes to site leadership.
• Identify opportunities to improve process performance, reduce costs, increase efficiency, and strengthen operational reliability in a GMP manufacturing environment.
• Promote data integrity, continuous improvement, and a strong compliance culture.
• Support regulatory inspections and audits as an MS&T technical representative.

• Bachelor’s degree in Engineering, Biotechnology, or a related scientific or technical discipline.
• At least 4 years of relevant experience in pharmaceutical, biotechnology, or another FDA-regulated manufacturing environment.
• Working knowledge of GMP requirements and FDA, EMA, and ICH guidelines, including ICH Q8 through Q11.
• Experience supporting technical documentation, process troubleshooting, and cross-functional collaboration.
• Strong analytical, organizational, project planning, written communication, and verbal communication skills.
• Ability to solve technical problems in a highly regulated GMP environment.
• Ability to manage multiple priorities and adapt to changing project and operational needs.
• Experience with process validation, PPQ strategy, or CMC regulatory submissions is preferred.
• Familiarity with statistical software such as JMP or Minitab and project management tools is preferred.
• PMP, Six Sigma Green Belt, or another relevant project management or continuous improvement certification is preferred.
• Experience with biologics or sterile manufacturing processes is preferred.

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