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Senior Manager, Equipment Commissioning & Qualification - Libertyville Illinois
Company: Disability Solutions Location: Libertyville, Illinois
Posted On: 05/04/2024
Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .Position SummaryThe Senior Manager, Equipment Commissioning & Qualification supports the successful operation of laboratory and commercial manufacturing operations at a product site through interaction with internal team members and peer-level customers as well as external service providers. The incumbent in this role will support entry, junior, and experienced level professionals at the Libertyville Vector Manufacturing Facility (VMF), tasked with performing on demand, and qualification/requalification, periodic review activities of equipment according to established policies and procedures. In addition to answering questions and resolving issues for staff, the incumbent spends a portion of their time on individual work or improvements. The incumbent may lead modifications to work processes or procedures to functional management that impact their immediate function or organizational unit.Key Responsibilities Management Responsibilities: - Leading a team of up to 10 contract personnel.
- Interview and hire internal and / or external personnel to fill necessary roles.
- Provide direction to internal and external team members.
- Ensure team members are appropriately trained for duties being performed.
- Promote and ensure the safety of all team members and adherence to site EHS procedures and guidelines.
- Ensure the team is in full compliance with local, site and global policies and procedures. Operational Activities:
- Delivers on Equipment Commissioning & Qualification activities, including scheduling, execution, and documentation of calibration, maintenance, repair, and equipment performance verification activities in both laboratory and manufacturing areas in Libertyville facilities.
- Leads investigations into deviations, performance verification failures and develops and implements corrective and preventive actions (CAPAs) and supports associated activities per function as needed.
- Initiate and own change controls, implements and supports associated activities per function as needed.
- Develop, review and/or approve all qualification life cycle documents (e.g., SIA, Engineering Studies, Qualification Plan, URS, FS, DS, IOQ, PQ, and VSRs).
- Ensures compliance with Validation Master Plans.
- Coordinates and supervises vendors for preventative maintenance, calibration, and performance verification functions.
- Develops and reviews written procedures for commissioning, qualification, and performance verification of equipment.
- Maintain the equipment and instruments in a validated state.
- Creates and maintains with the creation of departmental metrics. Understand and review departmental metrics. Promotes and provides excellent customer service and support:
- Regularly reviews, prioritizes, and promptly responds to customer equipment qualification/requalification, periodic review, and support requests.
- Provides technical support and guidance on equipment qualification/requalification, periodic review, and validations issues. Interfaces with customers to ensure all expectations are being met.
- Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment. Inventory Management:
- Work with Asset Cycle group to ensure system is updated as qualification/requalification, periodic review activities are performed. Service Contract Support:
- Manages Vendor service contracts to support equipment and systems including request for proposal development and manages bid process.
- Provide feedback to departmental leadership on vendor performance and needs. Regulatory Responsibilities:
- Ensure Equipment Commissioning & Qualification program is maintained in compliance.
- May be called upon to act as SME in both internal and regulatory audits.Qualifications & Experience
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