MS&T Engineer - Dallas, Texas

MissionHires; Dallas (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

MissionHires is seeking an MS&T Engineer to provide technical support for commercial pharmaceutical manufacturing in an FDA-regulated environment. You will lead technology transfers, process characterization, scale-up, troubleshooting, and lifecycle improvements in collaboration with Manufacturing, Quality, Regulatory Affairs, and Development teams.

Responsibilities include designing DoE studies, developing process validation plans, and contributing to regulatory filings while maintaining data

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, or a related discipline.
• At least 4 years of experience in FDA-regulated manufacturing (pharma/biotech).
• Working knowledge of GMP requirements and ICH/Q8–Q11 guidelines.

Responsibilities

• Lead and support technology transfer activities for new or modified manufacturing processes.
• Design, plan, and execute DoE and multivariate scale-up studies with statistical analyses.
• Prepare engineering protocols, reports, and GMP-compliant documentation.

Skills

GMP compliance

DoE

Multivariate analysis

Project management

Data integrity

Cross-functional collaboration

Statistical analysis

Written communication

Education

Bachelor's degree

Tools

JMP

Minitab

Project management tools

Job description

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.

Responsibilities:

• 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.

Requirements:

• 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.