- Manage the work order system, driving logical sequencing of plant support activities.
- Create calibration and preventative maintenance work orders within the CMMS.
- Ensure assigned calibrations and performance maintenance are completed on time.
- Coordinate with departmental supervisors to assign work orders to personnel for scheduled and unscheduled PM and maintenance activities.
- Publish reports as needed to provide visibility to departmental leadership regarding planned, completed and outstanding work orders.
- Work in a collaborative team environment and interact with other support groups such as Manufacturing, PD, QC, MS&T, and Quality Assurance.
- Develop, review, and approve accurate documentation, as required in cGMP operations.
- Perform equipment and system calibrations, cGMP equipment preventive maintenance, and electronically document all activities within the CMMS system.
- Review work orders for accuracy in accordance with Good Documentation Practices prior to closure.
- Manages assigned deviation, CAPA, and change control activities.
- Supports internal audits and CGMP readiness.
- Overall management of the computerized maintenance management system
- Review Calibration and preventative maintenance work orders, data, plans, change controls, etc., as required.
- Provide leadership and technical assistance to less experienced technicians.
- Perform SOP and Calibration Procedure revision, review, and approval.
- Generate deviations, CAPAs, perform investigations and root cause analysis.
- Work with Quality Assurance on the revision of Calibration and preventative maintenance documents.
- Represent Metrology department in relevant project management meetings.
- Bachelor's degree (or equivalent) in engineering/science and 5+ years' experience or High School degree with 6+ years' relevant experience.
- Hands-on experience with calibration in Biotech, Pharmaceuticals or Medical Device operations, including procedure development and field execution.
- Working knowledge of Calibration Programs
- Ability to develop and/or review calibration procedures using design documents and user requirements.
- Excellent technical writing and verbal communication skills
- Ability to Investigation/troubleshooting system/testing failures
- Ability to read/interpret engineering drawings (e.g. P&IDs, PFD's)
- Proficiency in CMMS programs such as BMRAM or Qualer.
- Microsoft Office including Word, Excel, PowerPoint and Project.
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Sr. Calibration Administrator - Hopkinton, United States - Roslin CT US Holdings,LLC
2 weeks ago
Description
Job Description
Job DescriptionWHO WE ARE
RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.
THE ROSLINCT WAY
Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients.
ACCELERATING YOUR FUTURE
The Sr. Calibration Administrator will lead equipment enrollment activities, plan, prioritize, schedule, and coordinate corrective and preventive maintenance work orders for all operational groups as well as manage all work orders from initiation to closure. The ideal candidate will understand equipment lifecycle, and have experience with BMRAM, CGMP, and Qualer within Cell and Gene Therapy. They will also provide oversight of the in-house Metrology program and perform equipment and systems calibration and preventive maintenance (as required) to ensure adherence to world-wide regulatory requirements and corporate standards. The Sr. Calibration Administrator will collaborate with validation on commissioning activities, schedule and oversee external support, maintain calibration standards, and collaborate with Quality Assurance.
HOW YOU WILL MAKE AN IMPACT
WHAT YOU WILL BRING
OUR COMMITMENT
All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.
RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.
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