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Key Responsibilities and Required Skills for an MS&T Engineer

💰 $ Competitive - $ Commensurate with Experience

EngineeringBiotechnologyPharmaceuticalManufacturingScience

🎯 Role Definition

As our next Manufacturing Science & Technology (MS&T) Engineer, you will be the technical cornerstone of our manufacturing operations. You are the subject matter expert (SME) for drug substance or drug product manufacturing processes, ensuring that our life-changing therapies are produced robustly, efficiently, and in strict compliance with global regulatory standards. This high-impact role requires a blend of deep scientific understanding, hands-on engineering prowess, and a collaborative spirit to solve complex challenges and drive continuous improvement from the lab bench to full-scale production. You will be instrumental in safeguarding our process integrity, leading technology transfers, and championing innovation on the manufacturing floor.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Process Development Scientist / Associate
  • Manufacturing Associate / Specialist
  • Quality Engineer / Scientist

Advancement To:

  • Senior MS&T Engineer
  • MS&T Manager / Principal Engineer
  • Director of Manufacturing or Process Sciences

Lateral Moves:

  • Process Engineering Manager
  • Quality Assurance Manager
  • Project Management (Technical)

Core Responsibilities

Primary Functions

  • Spearhead and meticulously manage end-to-end technology transfer activities for new and existing bioprocesses from development labs or external partners to commercial cGMP manufacturing sites.
  • Act as the primary technical subject matter expert (SME) for manufacturing processes, providing on-the-floor support, troubleshooting, and real-time decision-making during production campaigns.
  • Author, review, and approve critical technical documentation, including process descriptions, manufacturing batch records, process validation protocols, and summary reports to ensure regulatory compliance.
  • Lead and execute process validation (PV) lifecycle activities, including process design, process qualification (PQ), and continued process verification (CPV) to demonstrate process control and consistency.
  • Drive process optimization and continuous improvement initiatives aimed at enhancing process robustness, increasing yield, reducing cycle times, and improving the overall cost of goods.
  • Conduct in-depth investigations into process deviations, discrepancies, and out-of-specification (OOS) results, utilizing root cause analysis tools and implementing effective corrective and preventive actions (CAPAs).
  • Establish and maintain a robust process monitoring program using statistical process control (SPC) and data analysis to ensure processes remain in a state of control and to proactively identify trends.
  • Develop and maintain scale-down models that accurately represent the commercial manufacturing process to support process characterization, validation, and investigation activities.
  • Serve as the technical liaison between Manufacturing, Process Development, Quality Assurance, Quality Control, and Regulatory Affairs to ensure seamless alignment and project execution.
  • Evaluate and implement new manufacturing technologies and raw materials to enhance process performance, compliance, and efficiency.
  • Lead technical risk assessments (e.g., FMEA) for manufacturing processes to proactively identify and mitigate potential failure modes.
  • Generate, analyze, and trend large datasets from manufacturing operations and laboratory studies to provide actionable insights and data-driven recommendations.
  • Support regulatory submissions (e.g., IND, BLA, MAA) by authoring and reviewing relevant CMC (Chemistry, Manufacturing, and Controls) sections and responding to health authority inquiries.
  • Design and execute engineering studies, comparability protocols, and characterization studies to support process changes, equipment modifications, or raw material qualifications.
  • Provide technical training to manufacturing personnel on new processes, process changes, and the scientific principles underlying unit operations.
  • Oversee the lifecycle management of manufacturing processes, ensuring they remain state-of-the-art and compliant with evolving regulatory expectations.
  • Champion a culture of scientific inquiry and data-driven decision-making within the manufacturing and operational teams.
  • Manage joint process teams with external contract manufacturing organizations (CMOs) to ensure successful technical oversight and process alignment.
  • Author campaign summary reports that critically evaluate process performance, identify areas for improvement, and inform future manufacturing campaigns.
  • Support equipment and facility qualification and validation activities by providing critical process parameter (CPP) and critical quality attribute (CQA) expertise.

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis from cross-functional teams.
  • Contribute to the organization's digital transformation and data strategy roadmap.
  • Collaborate with business units to translate complex data needs into tangible engineering and system requirements.
  • Participate in sprint planning, daily stand-ups, and other agile ceremonies within the technical operations team.

Required Skills & Competencies

Hard Skills (Technical)

  • Deep expertise in biopharmaceutical manufacturing processes, including either upstream (cell culture, fermentation) or downstream (chromatography, TFF, viral filtration) unit operations.
  • Proven experience leading technology transfer, process scale-up, and process validation (PV) projects in a cGMP environment.
  • Strong proficiency in statistical data analysis and visualization using software such as JMP, Minitab, or R.
  • Thorough understanding of cGMP, FDA, and EMA regulatory requirements for biologics or pharmaceuticals.
  • Experience with Quality by Design (QbD) principles and conducting formal risk assessments (FMEA).
  • Hands-on knowledge of process control strategies, process monitoring systems, and data historians (e.g., PI System).
  • Technical writing proficiency with experience authoring BPRs, validation protocols, technical reports, and regulatory filing sections.
  • Familiarity with analytical methods used for in-process control, process characterization, and product release.

Soft Skills

  • Exceptional analytical, problem-solving, and critical-thinking skills to resolve complex technical challenges.
  • Outstanding collaboration and influencing skills to work effectively in a cross-functional, matrixed organization.
  • Excellent written and verbal communication skills, with the ability to present complex technical information clearly to diverse audiences.
  • Strong project management and organizational capabilities, with a proven ability to manage multiple projects and competing priorities.
  • A high degree of adaptability and resilience to thrive in a fast-paced, dynamic, and results-oriented environment.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's Degree (B.S.)

Preferred Education:

  • Master's Degree (M.S.) or Ph.D.

Relevant Fields of Study:

  • Chemical Engineering
  • Biochemical Engineering
  • Bioengineering
  • Biotechnology
  • Chemistry or a related life sciences discipline

Experience Requirements

Typical Experience Range:

  • 3-8+ years of relevant experience in the biopharmaceutical or pharmaceutical industry.

Preferred:

  • Direct experience in a process development, manufacturing support (MS&T), or technology transfer role within a regulated cGMP environment is highly preferred. Experience with both clinical and commercial stage products is a significant plus.
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