The Sr. Metrologist is responsible for maintaining the instrument quality program including the maintenance, qualification, and repair of laboratory instrumentation and equipment.
location: Exton, Pennsylvania
job type: Permanent
salary: $80,000 - 85,000 per year
work hours: 9 to 5
- Maintain the instrument quality program which includes:
- Preventive maintenance
- Instrument asset management and life cycle
- Laboratory facilities equipment
- Act as the point of contact for SAP calibration and maintenance module for Laboratory equipment
- Execute on strategies to control costs, reduce risks and improve productivity
- Write and execute IQs, OQs, and validation protocols as necessary
- Write documents such as laboratory investigations, work instructions, and standard operating procedures
- Train and mentor new metrology employees on preventative maintenance and SAP processes.
- Train laboratory personnel and vendors on applicable policies and procedures pertaining to equipment and instrumentation.
- Identify equipment constraints due to equipment downtime and maintenance schedules and provide recommendations to Operations personnel for minimizing impacts.
- Collaborate with Laboratory Operations to determine qualifications required for new instrumentation
- Collaborate with Laboratory Operations and Facilities Management to maintain and improve Laboratory Facility
- Utilize SAP to perform change control, corrective and preventative actions and investigations.
- Drive vendor relationships and discussions on lab equipment to ensure instrument needs within Analytical Services are communicated and implemented
- Provide support and assistance with laboratory equipment, instrument and facilities 24/7 in order to maintain laboratory operations
- Drive continuous improvement using metrics for instrument repair history and response time
- Assist and participate in customer and regulatory audits for Metrology
- Provide budgeting information for new instruments, service agreements, etc.
- Keep current with new technologies and cGMP regulations.
- Implement continuous improvement/lean activities and events for the group
- Bachelor's degree in a life science discipline (biology, chemistry, forensic science)
- 5 - 10 Years of experience in analytical metrology
- Minimum of 5 years of experience in repair, maintenance and calibration of analytical instrumentation
- Advanced instrumentation and controls troubleshooting skills
- Knowledge of calibration accuracy testing requirements and metrology
- Understanding of regulatory guidelines such as Z40, 17025, ISO and cGXP
- Experience in cGLP preferred
- Effectively communicate with customers, vendors and team members
- Make informed decisions in regards to critical processes and potential issues to prevent downtime
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Support and contribute in Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the company's safety & quality policies at all times
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.