Bristol Myers Squibb Manager, ECQ Operations in Summit, New Jersey
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
PURPOSE AND SCOPE OF POSITION:
The Manager, Equipment Commissioning & Qualification Operations supports the successful operation of laboratory operations at a multi-product site through interaction with internal team members and peer‐level customers as well as external service providers. The incumbent in this role managers entry, junior, and experienced level professionals at the Summit West S7 Facility, tasked with performing on-demand, preventative maintenance, calibration, and performance verification 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 recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit.
EDUCATION AND EXPERIENCE
BS in Engineering or Science related discipline preferred.
Minimum 5 years’ experience in FDA-regulated industry.
Minimum 3 years of managing personnel including maintenance coordinating and planning experience, preferably in a laboratory environment.
Minimum 3 years’ experience working directly with bench top laboratory equipment (HPLC’s, GC’s, Dissolution stations, balances, meters, etc.) required.
Working knowledge of cGMP in the pharmaceutical industry.
Excellent computer skills including working knowledge of calibration, documentation, deviation and change management software and systems.
Strong problem-solving skills, strong verbal and written communication skills, high attention to detail and the ability to work independently.
Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Advanced knowledge of pharmaceutical and laboratory systems and equipment.
Innate ability to develop, delegate and motivate others including direct and indirect reports.
Strong understanding of scheduling fundamentals and execution.
Strong written and verbal communication skills with a high attention to detail.
Excellent interpersonal skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required.
Strong multi‐tasking ability in conjunction with proven organizational skills. Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks/assignments with others that may impact timely completion. Strong ability to effectively manage multiple tasks and activities simultaneously.
Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
Strong working knowledge of scheduling software and systems, and inventory management systems, mainly Blue Mountain RAM.
Advanced understanding of investigations, deviations, CAPA and change management in a regulated pharmaceutical industry.
Strong working knowledge of deviation and change management software and systems.
Innate ability to create and analyze meaningful metrics.
DUTIES AND RESPONSIBILITIES
Lead a team of up to 6 people including full time and contract personnel.
Interview and hire internal and/or external personnel to fill necessary roles.
Provide direction to internal and external team members.
Manage the workload of team members to ensure appropriate work life balance.
Delegate, develop and motivate direct and contract reports.
Deliver personnel performance reviews.
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 BMS policies and procedures.
Directly manages Equipment Commissioning & Qualification operations staff including the scheduling, execution, and documentation of calibration, maintenance, repair, and equipment performance verification activities in laboratory areas in Summit facilities.
Reviews and approves calibration, maintenance, repair and performance verification records for accuracy, completeness, and compliance to BMS standards.
Leads investigations into deviations and performance verification failures and develops and implements corrective and preventive actions.
Initiates, manages, and supports change controls for changes to equipment or systems.
Ensures compliance with Validation Master Plans.
Coordinates and supervises vendors for preventative maintenance, calibration, and performance verification functions.
Develops, reviews, and approves written procedures for calibration, preventive maintenance, and performance verification of equipment.
Maintains the calibration management system in a validated state.
Creates departmental metrics. Thoroughly understands and compiles departmental metrics.
Promotes and Provides Excellent Customer Service and Support
Regularly reviews, prioritizes and promptly responds to customer equipment performance verification and support requests.
Provides technical support and guidance on calibration, equipment performance verification 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.
- Work with planning group to ensure asset management system is updated as calibration, preventative maintenance, performance verification and on-demand repair activities are performed.
Service Contract Support
Assist with the management of Vendor service contracts to support equipment and systems.
Provide feedback to departmental leadership on vendor performance and needs.
Ensure equipment maintenance programs are maintained in compliance.
May be called upon to act as SME in both internal and regulatory audits.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1546532
Updated: 2021-09-23 02:34:23.137 UTC
Location: Summit,New Jersey
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.