MS&T Engineer

JOB TITLE: MS&T Engineer                                                 DEPARTMENT: Engineering

REPORTS TO: Engineering Management                            EMPLOYEE STATUS: Exempt

LOCATION: Onsite Only                                                        WORK AVAILABLE: Full-Time

SUMMARY

The MS&T Engineer plays a key technical role in supporting commercial manufacturing operations within an FDA-regulated pharmaceutical environment. This position focuses on technology selection, tech transfer, process characterization, technical problem-solving, and cross-functional project execution to ensure that manufacturing processes are robust, compliant, and optimized throughout their lifecycle.

DUTIES & RESPONSIBILITIES

Technical & Regulatory Support

• Execute and support technology transfer activities for new or modified processes, ensuring smooth transition from development to commercial manufacturing.

• Design, plan, and execute process characterization and scale-up studies, including statistical analyses (e.g., DoE, MVA).

• Develop and author engineering protocols, technical reports, and support documentation in compliance with GMP and regulatory requirements (FDA, EMA, ICH).

• Support deviation investigations, root cause analyses, and implementation of CAPAs related to process issues.

• Provide technical input into regulatory filings (e.g., IND, NDA, BLA, post-approval changes) and respond to regulatory queries.

Project Management

• Assist in or lead cross-functional projects, including technology transfer, process optimization, and lifecycle initiatives.

• Develop and maintain project timelines, risk assessments, and deliverables in coordination with Quality, Manufacturing, Regulatory Affairs, and Development teams.

• Organize and lead technical meetings; track action items and ensure timely closure.

• Support project reporting and communication to site leadership.

Operational Excellence

• Identify opportunities for process improvements, cost reductions, or efficiency gains within the GMP manufacturing environment.

• Champion data integrity, continuous improvement, and compliance culture.

• Support regulatory inspections and audits as a technical representative of MS&T.

REQUIRED QUALIFICATIONS

• Bachelor’s degree in Engineering, Biotechnology, or a related discipline.

• 4 years of relevant experience in pharmaceutical, biotech, or other FDA-regulated Mg. environments.

• Knowledge of GMP, FDA/EMA regulations, and ICH guidelines (Q8–Q11).

• Experience with technical documentation, process troubleshooting, and cross-functional collaboration.

• Strong organizational, analytical, and communication skills.

PRFERRED EXPERIENCE

• Experience with process validation, PPQ strategy, or CMC regulatory submissions.

• Familiarity with statistical tools (e.g., JMP, Minitab) and project management software.

• PMP, Six Sigma Green Belt, or other project management certifications.

• Experience with biologics or sterile manufacturing processes.

KEY COMPETENCIES

• Technical problem-solving in a GMP context

• Project planning and execution

• Regulatory and quality mindset

• Strong cross-functional communication

• Adaptability in a dynamic, highly regulated environment