Calibration - Calibration Technician Calibration Technician

LSM Calibration Technician

The LSM Calibration Technician supports the successful operation of laboratory and clinical manufacturing operations at their home site through interaction with internal team members and internal customers, and external service providers. The role requires knowledge of cGMP and good documentation practices, pharmaceutical, manufacturing and laboratory systems and equipment. Strong problem-solving skills, the ability to work independently, excellent interpersonal and communication skills, and proficiency in Microsoft Office Suite are essential.

The technician must also have strong multi-tasking and organizational abilities, and the ability to effectively manage multiple tasks and activities simultaneously. Working knowledge of scheduling software and systems, and inventory management systems is preferred. The technician will interact effectively with QC, Manufacturing, QA, and Engineering & Facilities groups.

Operational activities include executing equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas. The technician will also supervise vendors for calibration, preventative maintenance, performance verification and repair functions, review and approve vendor records, and document and populate calibration/maintenance information in CMMS system. They will execute requalification on Controlled Temperature Units, support multiple sites within Warren and Summit, and support clinical manufacturing on-call equipment troubleshooting activities during weekends as required.

The technician will ensure all calibration, PM, and performance verification records are filed appropriately after approval, contact suppliers for quotation on external calibration/PM of the equipment and calibration standards, and initiate, participate, and assist in resolution of quality investigations.

The technician will author and support the development, revision, and review of written Standard Operating Procedures (SOP) for calibration, preventive maintenance, and performance verification of instruments/equipment. They will support the development, review and approval of calibration and maintenance plans in site CMMS system, and support the execution of process improvement studies, as required. The technician will adhere to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards, perform inventory of the equipment and/or standards in the labs as required, and maintain a positive relationship with the site customers and outside vendors while promoting a positive team environment.

The technician will participate actively in special projects as required, ensure low cost of the Laboratory Systems Management (LSM) department, and plans, justify and implement cost reduction small projects. They will follow cGMP and ALCOA principles, work with planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed, and perform client's investigations. The technician will maintain all required Corporate, Facilities and EHS training as required, and adhere to all safety procedures and hazard communication.

Education and experience required include a high school diploma or associates or bachelor's degree, and 3+ years of lab experience preferred in pharma or medical device industry or manufacturing.

Physical and mental demands include occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25 lbs. The ability to sit, stand, walk, and move within workspace for extended periods is required, as well as the ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling. The environment may include working in office, laboratory, or manufacturing area, and proper gowning and/or PPE such as safety glasses and shoes in an environment with hazardous materials and waste will be required.

Working safely and effectively when working alone or working with others will be required.