Manufacturing Engineer III

Responsibilities

• Lead the development, execution, and approval of validation master plans, validation plans, IQ/OQ/PQ protocols, and final reports, with emphasis on sterilization, endotoxin control, and microbiology-related processes.
• Support process design transfer activities, ensuring manufacturing readiness and regulatory compliance.
• Perform statistical analysis to support validation data, conclusions, and technical reports.
• Develop and implement change controls, engineering change orders (ECOs), and engineering notices.
• Create statistically justified sampling plans for in-process controls, final inspections, and validation activities.
• Troubleshoot equipment and manufacturing processes that fail to perform as expected during validation or production runs.
• Identify and recommend process and quality improvements based on validation outcomes and operational feedback.
• Investigate, document, and resolve nonconformances, protocol deviations, and CAPA activities, including authoring investigation reports.
• Serve as a key contributor on cross-functional project teams, collaborating with Manufacturing, Engineering, Quality, Regulatory, Facilities, Microbiology, suppliers, and external partners.
• Ensure all activities comply with FDA, ISO, GMP, OSHA, EPA, and applicable international regulatory standards. Support the preparation and review of technical documentation for domestic and international regulatory submissions.
• Participate in and support external audits and inspections, including FDA, Notified Bodies (e.g., BSI), and corporate audits. Perform additional duties as required to support manufacturing and quality objectives.

• Strong working knowledge of FDA, ISO, GMP, OSHA, and EPA regulations.
• Demonstrated experience with risk management, CAPA, and continuous improvement methodologies.
• Proven project management skills, including the ability to lead complex, cross-functional initiatives.
• Ability to provide technical leadership and guide teams through challenging manufacturing and validation activities.
• Excellent written and verbal communication skills with a history of effective cross-functional collaboration.
• Strategic thinker with strong problem-solving and decision-making abilities.
• Hands-on experience authoring and maintaining technical documentation, including:
• Validation plans and protocols, Change controls and ECOs, Investigation and technical reports, SOPs and work instructions
• Bachelor's degree in Engineering or Science, preferably Mechanical, Industrial, Electrical, Chemical, Biomedical, or a related discipline.
• Lean / Six Sigma Green Belt or Black Belt certification preferred.
• Demonstrated experience in validation of manufacturing equipment, processes, stability, or aging studies.
• Minimum of 7+ years of experience in a medical device and/or pharmaceutical manufacturing environment.