MS&T Engineer

ADP, Inc.; Dallas (TX); On-site; USD 95,000 - 130,000; Full time

Job summary

ADP, Inc. in Dallas, TX seeks a MS&T Engineer to support commercial manufacturing operations in an FDA-regulated environment. You will drive technology transfer, process characterization, and cross-functional project execution to ensure robust, compliant processes throughout their lifecycle.

The role emphasizes DoE, MVA analyses, GMP compliance, and close collaboration with Quality, Regulatory, Manufacturing, and Development teams to enable efficient scale-up and lifecycle improvements.

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, or a related discipline.
• 4 years of relevant experience in pharmaceutical, biotech, or FDA-regulated 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.

Responsibilities

• Execute and support technology transfer activities for new or modified processes.
• Plan and execute process characterization and scale-up studies, including DoE and MVA.
• Develop engineering protocols, technical reports, and GMP/regulatory documentation.
• Support deviation investigations and CAPA implementation.
• Provide input into regulatory filings and respond to regulatory queries.

Skills

GMP knowledge

Regulatory/Quality mindset

Project planning & execution

Analytical skills

Communication skills

Education

Bachelor's degree in Engineering, Biotechnology, or related discipline

Tools

JMP

Minitab

Project management software

Job description

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Full Time Professional Dallas, TX, US

2 days ago Requisition ID: 1018

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
• Adaptability in a dynamic, highly regulated environment