Engineering - Equipment Engineer

LSM Equipment Engineer

The LSM(Lab Systems Management) Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers. The incumbent conducts tasks assigned by the management independently or with minimum supervision. The LSM Equipment Engineer is responsible for initiating and owning deviations, CAPAs, and change controls, and authoring calibration and maintenance SOPs as well as performing calibrations, maintenance, and qualifications/validations.

Required competencies include knowledge of cGMP and good documentation practices, pharmaceutical, manufacturing and laboratory systems and equipment, calibration management and environmental monitoring systems. The candidate should have strong critical thinking skills, the ability to work independently, excellent interpersonal and communication skills, strong multi-tasking and organizational ability, and proficiency in Microsoft Office Suite.

Duties and responsibilities include executing equipment calibration, preventative maintenance, performance verification and repair activities in laboratory and manufacturing areas, supervising vendors for calibration, preventative maintenance, performance verification and repair functions, reviewing and approving vendor executed calibration, maintenance, repair, and performance verification records, executing requalification on Controlled Temperature Units, supporting multiple sites within Warren and Summit, owning and supporting deviations and investigations that result from calibration or performance verification activities, authoring and supporting the development, revision, and review of written procedures for calibration, preventive maintenance, and performance verification of equipment, supporting the development, review and approval of calibration and maintenance plans in site CMMS system, supporting the execution of process improvement studies, adhering to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards, maintaining a positive relationship with the site customers and outside vendors while promoting a positive team environment, and following cGMP and ALCOA principles.

Inventory management duties include working with the planning group to ensure the system is updated as calibration, maintenance and performance verification activities are performed, approving Change Request, Asset Inductions, and Work Request, approving Calibration and Maintenance forms, performing client's investigations, and reviewing and approving calibration and maintenance work.

Regulatory responsibilities include maintaining all required Corporate, Facilities and EHS training as required, adhering to all safety procedures and hazard communication, and may be called upon to act as SME in both internal and regulatory audits.

Education and experience requirements include a BS in Engineering or Science related discipline, minimum 2 years of experience in FDA-regulated industry, minimum 3 years of experience working directly with laboratory equipment, maintenance coordination/planning experience preferred, and experience working in a clinical environment preferred.

Working conditions include occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25 lbs, ability to sit, stand, walk, and move within workspace for extended periods, ability to perform repetitive tasks, including hand to finger manipulations, grasping, pushing, and pulling, working in office, laboratory, or manufacturing area, donning proper gowning and/or PPE such as safety glasses and shoes in an environment with hazardous materials and waste, and working safely and effectively when working alone or working with others.