Technician, Advanced Operations

Responsibilities

• Coordinate laboratory equipment activity to satisfy demands
• Commission equipment and prepare and execute IQ, OQ and PQ activities as required
• Develop and implement best practices for laboratory activities
• Create and maintain Standard Operating Procedures, maintenance procedures, and Health and Safety procedures
• Perform all necessary laboratory and Product Development testing and supply data required for FDA submissions
• Conduct metallographic, optical microscopy, chemical and physical analysis, dimensional measurement, First Article Inspection, etc., on metals, polymers, and other materials as required
• Conduct DOEs, capability studies, MSAs, write technical reports, provide technical support, address workmanship standards, resolve product quality issues, support quality control, and facilitate engineering support such as ECN generation
• Support 3D Printing prototyping: prepare CAD files, convert to STL, prepare and operate the 3 D printer, perform post processing and inspection
• Work closely with the Quality Department to ensure documentation associated with validation and new product introduction in a regulated environment is accurate, executed in the correct sequence, and completed promptly
• Participate in PFMEA, Control Plan, SOP, and PPAP generation for product transfers and launches
• Provide training for manufacturing team members
• Ensure adherence to GMP and safety procedures
• Perform all other duties as assigned

Qualifications

• Diploma/trade in a related discipline
• Minimum of 2 years of experience as a technician or in a technical role
• Knowledge of metallographic preparation
• Knowledge of ASTM and ISO specifications
• Strong computer literacy
• Experience with validation activities in a regulated industry
• Demonstrated mechanical/technical aptitude
• Strong communication skills
• Ability to work independently and as part of a team in a fast paced, results oriented environment
• Proven problem solving skills and a hands on approach
• Experience working in a regulated GMP based machine floor environment
• Capable of working as part of a multi disciplined team
• Ability to meet timelines and adhere to deadlines
• Attention to detail and accuracy when completing documentation

Work Flexibility

23 month fixed term contract. The role allows up to 10% travel. Working arrangements can be 100% remote, onsite, or hybrid depending on the assignment location.