Technician, Advanced Operations

Coordinate laboratory equipment activity to satisfy demands 

Commission equipment and prepare and execute IQ, OQ and PQ activities as .  

Develop and implement best practices for laboratory activities.  Creation and maintenance of Standard Operating Procedures, maintenance procedures and Health and Safety procedures. 

Perform all necessary laboratory and Product Development testing and supply data  for FDA submissions. Equipment will include metallographic, optical microscopy, chemical and physical analysis, dimensional measurement, First Article Inspection, etc., of metals, polymers, etc., as required. 

Conduct DOEs, capability studies, MSAs, Technical report writing, Technical support, e.g. workmanship standards, product quality issue resolution, quality control support, engineering support, e.g. ECN generation. 

Support 3D-Printing prototyping. CAD file preparation, conversion to STL, 3D-printer preparation and operation, post-processing and inspection.   

Work closely with the Quality Department to ensure all documentation associated with validation and new product introduction in a regulated environment is accurate, executed in the correct sequence and completed in a timely manner. 

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. 

All other duties as assigned. 

Holds a diploma/trade in a related discipline.  

Has a minimum of 2 years of experience as a technician/in a technical role 

Knowledge of and experience in 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 on own initiative as part of a team in a fast-paced, results-oriented environment. 

Proven problem-solving skills and 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 work to and meet timelines essential. 

Attention to detail and accuracy when completing documentation is essential.