Ecocareers ยท 1 week ago
Manufacturing Engineer III
Andover, MA
Full-time
Onsite
Senior Level
7+ years expEcocareers is a company seeking a Manufacturing Engineer III to lead the development and execution of validation processes. The role involves ensuring manufacturing readiness, regulatory compliance, and supporting cross-functional project teams in a medical device or pharmaceutical environment.
Staffing & Recruiting
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
Qualification
Required
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
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
Preferred
Lean / Six Sigma Green Belt or Black Belt certification
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase