ECI · 5 hours ago
Cleanroom, Equipment and Process Validation Engineer (Med Device) #4421
Westborough, MA
Full-time
Onsite
Senior Level
7+ years expECI is a global leader of professional consulting services for the life sciences industry, seeking a Cleanroom, Equipment and Process Validation Engineer. The candidate will develop, optimize, and scale manufacturing processes for client products, ensuring compliance with regulatory requirements and supporting the transition from R&D to manufacturing.
BiotechnologyConsultingLife ScienceProject Management
No H1B
U.S. Citizen Only
Responsibilities
Design, develop, and optimize manufacturing processes
Collaborate with R&D during design transfer to ensure manufacturability, scalability, and compliance with regulatory requirements (e.g., FDA, ISO 13485)
Support manufacturing tech transfer
Develop a process validation protocols (IQ/OQ/PQ), DOE studies, and risk assessments (FMEA)
Support current process-related CAPAs, NCRs (NCMRs) as a CAPA/NCR owner
Identify automation opportunities to improve yield, throughput, and product consistency
Generate a list of the required technical documentation including SOPs, batch records, validation reports, and engineering change orders
Evaluate new equipment, materials, and technologies for integration into manufacturing processes
Qualification
Required
Bachelor's Degree in Engineering or equivalent work experience
Minimum of 7 (seven) years direct process engineering experience in medical device industry
Good analytical and problem solving skills
Excellent written and verbal communication skills with good presentation and technical writing skills
Collaborative attitude with the ability to work well in a team environment
Strong engineering, design, and analysis skills
Working knowledge of tooling and manufacturing processes
Experience with medical devices from concept to commercialization
Understanding of FDA Quality Systems Regulations
Company
ECI
ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Michael Boyer
Chief Financial Officer
Shital Patel
Chief Operating Officer
Company data provided by crunchbase