MSAT Associate Principal Engineer

About the role

The MSAT Associate Principal Engineer serves as the primary technical support person for manufacturing processes. This role involves developing a core competency in transferring and supporting processes from first run in plant, PPQ campaigns, and commercial campaigns.

Responsibilities

• Serve as a technical lead for technology transfer, validation, and lifecycle management initiatives.
• Collaborate with customer technical and quality representatives as the technical SME to represent MSAT on project teams.
• Develop process understanding and expertise to successfully implement manufacturing solutions.
• Author, review, and own process-related documentation to ensure flawless execution.
• Capture, review, and approve process documentation.
• Coordinate change controls and lead all aspects of the implementation of changes as the assigned change agent.
• Maintain and update process documentation.
• Monitor and report on process performance through detailed data analysis and live presentations.

Requirements

• Minimum of Bachelor of Science degree required, preferably in Biotechnology, Biological Sciences, or Chemical Engineering.
• 8+ years of experience in the biopharmaceutical industry (6+ years of experience with Master’s, 5+ with PhD) with a strong background in manufacturing science and technology functions, including biotech processes, process development, scale-up, tech transfer, and manufacturing.
• Proven knowledge of aseptic techniques and cell culture.
• Experience with bioreactor operation and scale-up.
• Excellent ability to effectively communicate ideas and points of view, both orally and in written form.
• Demonstrates strong interpersonal skills and a dedication to excellence.
• Prioritizes safety awareness at all times and carefully considers the impact of actions before completing activities.
• Ability to share 24/7 on-call support while the process is being manufactured.

Qualifications

• Strong technical skills in manufacturing science and technology functions.
• Experience with biopharmaceutical manufacturing processes.
• Knowledge of regulatory requirements and compliance.
• Experience with process validation and lifecycle management.

Skills

• Technical writing and documentation skills.
• Process improvement and optimization skills.
• Change management and project coordination skills.
• Leadership and team collaboration skills.
• Problem-solving and analytical skills.
• Communication and presentation skills.

Benefits

• Competitive compensation and benefits package.
• 401(k) matching plan.
• Supportive leadership and mentoring.
• Commitment to ethical and sustainable practices.
• Access to global benefits.