Location: Buena, NJ
•Be the point of contact for Laboratory, Utilities and Operations calibration program.
•Set up the Master Data for the Calibration Program.
•Approve all calibration work order execution, as required. Ensure all calibrations are executed on time.
•Develop and implement a calibration system that meets industry Quality Standards and utilizes Mean Time To Repair, Mean Time Between Failure, Failure Mode Effect Analysis, Criticality Assessment and other good calibration practices for the site. Develop and implement metrics to measure the calibration program execution. Use process excellence tools to optimize the calibration program.
•Work in collaboration with the Engineers, Calibration Technicians, System Owners and QA in conducting Root Cause Failure Analysis (RCFA), recommend, implement and monitor corrective actions for equipment failures and critical system/process failures and utilize analysis and trending techniques to support continuous improvement in the cost of operating and maintaining site assets.
•Adjust equipment plans and frequencies to optimize performance.
•Troubleshoot equipment problems with maintenance to minimize downtime.
•Lead the storage, maintenance and asset care of the calibration equipment. Lead calibration (transactions, conducting, and closing) activities. Report deviation and escalate to management. Support deviation and non-conformance investigator. Perform required check/sampling and testing as per batch record and standard operating procedure directives.
•Lead the criticality instrument analysis, maintain the calibration procedures, calibration records, calibration standards
•Participate as the site lead for vendor selection and auditing
•Other duties as assigned.
•A minimum of a Bachelor’s degree in Engineering, Science, or Business is required.
•A minimum of 5 years of experience in a Calibration in a medical device and/or pharmaceutical industry is preferred
• Experience in the SAP PM and Calibrations module is preferred.
• Experience in calibrating Laboratory, Utilities and Operations equipment is required.
• Must be able to work on multiple projects with accelerated timelines.
• Excellent organizational skills and attention to detail is required.
• Excellent computer, communication, and written skills are required.
• Proficient in Microsoft WORD, Excel, and PowerPoint required.
• Demonstrated results in manufacturing maintenance operations.
• Knowledge of FDA, EMA and cGMP regulations.
• Demonstrate ability to interact, motivate and lead individuals in a manufacturing environment.
• Demonstrate analytical skills, process and data driven orientation, the ability to effectively resolve technical issues is required.
• Knowledge of company, industry, and regulatory standards and data-based decision to include root cause analyses, cost/benefit, and risk assessment.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to talk or hear.
• The employee frequently is required to stand; walk; use hands to handle or feel; and reach with hands and arms.
• The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.