Metrology Engineer will be responsible for scheduling and coordinating qualification activities (e.g. Installation Qualification, Operational Qualification, and Performance Qualification), calibration, and maintenance activities for GMP facilities, equipment and instruments as required.
- Calibrates/verifies/qualifies and performs preventative maintenance on manufacturing and laboratory equipment which includes, but is not limited to, HPLC, UPLC, GC, FTIR, etc.
- Manage instrumentation master listing. Maintains the equipment historical records in an organized manner including electronic and paper records. Ensures that equipment records are maintained according to GDP.
- Inspects, evaluates, troubleshoots, and repairs manufacturing and laboratory equipment when problems arise.
- Documents, reviews, and audits calibration/maintenance/repair activities of manufacturing and laboratory equipment.
- Maintains calibration/maintenance schedules to keep the Calibration Program up to date.
- Maintains inventory and researches options on prices and availability of parts.
- Writes or contributes to qualification protocols and reports. Writes SOPs, and instrument qualification plans.
- Supports GMP staff with individual qualification and/or validation plans.
- Assists in the compilation of regulatory submissions and in the completion of non-conformance investigations, corrective and preventive actions, risk assessments, and change requests.
- Records and reports out-of-tolerance results and any other instrument-related issues to the manager and performs corrective and preventive actions as directed.
- Maintains compliance with all company policies, plans and procedures, including safety, security and regulatory.
- Aids in laboratory investigations due to instrument-related issues when needed.
- Explores ways that maximize efficiency at lower costs.
- Performs other duties as assigned.
- Manages vendor site visits and training records.
- Monitors Facility System activities.
- Bachelor’s degree in science with a strong preference for a degree in Chemistry or Engineering.
- Preferred to have at least 5 years relevant experience in a GMP or highly regulated environment.
- Preferred to have at least 3-5 years validation experience.
- Experience with compliance and quality improvement.
- Essential skills include high attention to detail, the ability to multi-task, and the ability to work independently.
- Having a positive team-oriented attitude, a willingness to take initiative, and the ability to rapidly comprehend and communicate technical material are critical attributes.
- Proficient computer skills with documentation related databases, Microsoft Office, Excel, Outlook, SharePoint, MiniTab, and Adobe Acrobat and the ability to learn other software applications, as required.
- Ability to speak effectively before groups of customers or employees of organization.
- Time management and project management capabilities highly desired.