Technician, Advanced Operations

Coordinatelaboratory equipmentactivity to satisfy demands

Commissionequipmentand prepare and execute IQ OQ and PQ activitiesas.

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 ProductDevelopmenttesting and supply datafor 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.

Support3D-Printing prototyping. CAD file preparation conversion to STL3D-printer preparation and operation post-processingand inspection.

Work closely with the Quality Department to ensure all documentation associated with validation and new product introduction in a regulated environment isaccurate executed in the correct sequence and completedin 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 2years of experienceas 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 ina regulated industry

Demonstrated Mechanical/Technical Aptitude.

Strong communicationskills.

Ability to work on own initiative as part of a team in a fast-paced results-oriented environment.

Provenproblem-solvingskills 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 isessential.