Category: Scientific & Clinical
Title: Metrology Specialist
Location: New Brunswick, NJ
Schedule: 8am to 5pm Mon – Fri.
Start date: ASAP
- To provide leadership, technical expertise and implement and manage the calibration program, strategy and practice ensuring compliance (GMP and PSM) with company policies and appropriate regulatory standards
- Responsible for: metrology technical support as a Subject Matter Expert required for NBR R&D Manufacturing related production instrumentation.
- All planning, preparation, and on-time execution of all Metrology/Calibration work, i.e.: Shutdowns, corrective maintenance, preventative maintenance, predictive maintenance, etc.
- Define weekly instrument technician staffing strategy, scheduling of calibration activities, and maintenance/capital work across the NBR R&D Manufacturing areas.
- Understanding, approving, prioritizing and ensuring access is granted for all work in scope of the IFM vendor.
- Oversight of IFM calibration outcomes; reviews CPI/KPI/GPI where applicable.
- Working with groups within the NBR R&D Manufacturing space to provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipment.
- Manages: Day to day activities of the Instrumentation and Calibration group including training, deployment, work execution, work review and approvals; includes IFM & 3rd party vendor work as well.
- Metrology team with responsibility over all Calibration Data Sheets and Metrology Job Plans Master Data within the CMMS system.
- Use and application of all Metrology Tools & Standards. This might require interfacing & coordination with IFM Calibration team
- The optimization of calibration frequencies through calibration interval management program including minimally invasive instrumentation tasks which support Calibration interval extension
- Safety investigations/Near Miss program and Corrective Measure implementation relevant to calibrations across the NBR R&D Manufacturing facilities.
- Change control program across the NBR R&D Manufacturing facilities.
- Serve as a reviewer and approver of change controls.
- Day-to-day activities for calibrations within the NBR R&D Manufacturing Direct Impact systems.
- Knowledge of metrology, calibrations, instrumentation, automation and electrical practices generally attained through hands-on experience.
- High School Diploma Required
- 5 years of experience in pharmaceutical operations and drug product intermediates along with the manufacture, packaging & labeling, and distribution of drug product in a manufacturing plant or pilot plant.
- Prior management experience a plus.
- Knowledge of process control and instrumentation in a regulated (cGMP & PSM) pharmaceutical facility.
- Thorough understanding of metrology principles and practices including calibration methods and tolerances.
- Ability to prioritize and coordinate activities within and between work groups. Able to discern priority differences and resolve issues.
- Ability to effectively interact with individuals at all levels and groups from various departments.
- Expert knowledge of SOPs and cGMPs, and the know how to work and manage within a regulatory environment.
- Working knowledge of company procedures and policies.
- Adaptable to a fast paced, complex and ever changing business environment
- Effective communication skills, verbal and written; demonstrated proficiency in technical writing
- Knowledge of Maximo (CMMS), Emerson Delta V, Emerson AMS, PI, Trackwise, , Vault, PDHQ (Procedural Documents Headquarters), Microsoft Suite, EIMS (Electronic Incident Management System)
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.