Senior Supervisor Equipment Commissioning amp Qualification ECQ

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Bristol Myers Squibb
Senior Supervisor, Equipment Commissioning & Qualification (ECQ)
in
Summit
New Jersey
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Pur p ose of the Pos i t i on:
The Senior Supervisor, Equipment Commissioning & Qualification (ECQ) Delivery supports the s u c c e s sful operati o n of facility, lab o ratory a nd bu s iness functions a t m ulti‐use sites t h r ou g h interaction with i nte r nal team me m bers and p e er‐level custome r s as well as external service providers. T he incumbent i n this rol e supervises entry , j unior, and experienced level professionals to acco m plish da i ly tasks a nd short‐term proj e cts a cco r ding t o established policies and pr o cedures. The i ndividual manages m ultiple proj e cts an d ongoing wor k activities of l ow to moderat e complexity t o ensure on time completion. In additi o n to answering questions and resolving issues f or s t aff, t he incu m bent s pe n ds a small portion of thei r time on indivi dual work. T he incumbent may recommend modifications to work processes or proce d ures to functional management t hat impact their i mmediate function or org a n i zational u n it.
Essential Func tion s:
Management Responsibilities
Lead a team of up to 5 people.
Assist with interviewing 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.
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 Celgene policies and procedures.
Commissioning and Qualification Activities
Directly manage Equipment Commissioning & Qualification equipment qualification teams.
Manage and allocate resources responsible for teams performing validation activities of new equipment and standalone laboratory computerized systems and/or changes to existing equipment and standalone computerized systems.
Manage project teams with emphasis on solutions to technical and compliance challenges in all phases of the System Lifecycle.
Oversee the Development/Review/Approval of SOPs, WPs, test protocols, validation deliverables, and plans as needed.
Ensure resources performing validation activities are knowledgeable of and in tune with latest industry regulations and initiatives.
Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.
Promotes and provides excellent customer service and support
Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
Provides technical support and guidance on equipment and computer systems qualification 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.
Communication and Management of Timelines
Manage staff workload of multiple projects and priorities across the many different departments that the ECQ organization serves.
Develop an effective mechanism for communicating the current status of all laboratory systems maintained by ECQ to all affected stakeholders.
Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.
Regulatory Responsibilities
Ensure equipment, facilities and programs are maintained in compliance.
Act as departmental lead and SME in both internal and regulatory audits.
Requi r ed Competencies ‐ Knowled g e, Skills, a n d Ab ilitie s :
Knowledge, S k ills & A b iliti e s:
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and Oral Solid Dosage clinical manufacturing.
Ability to develop, delegate and motivate others including direct and indirect reports.
Understanding of scheduling fundamentals and execution.
Stro n g written and verbal c o mmunicati o n s kills.
Excellent inte r personal skills with experience dealing with a diverse workforce.
Stro n g multi‐tasking ability in con j u n ction w i th prov e n o r g a nizational skills. Ability to organize assigned tasks in a hi g h pac e d environment and concurrently monitor tasks / assignments with o thers that may impact timely completion. Ability to e ffectively manage m ultiple tasks an d activities si m ultaneously.
Highly proficient c ompu t er skill s in Microso f t Off i ce Suite - Wo r d, Excel, P owerPoint and Outlook with extensive ba ck grou n d in da ta base systems. Innate ability t o learn new software, such as corpor a te intrane t and ente r prise business.
Working knowledge of scheduling software and systems, and inventory management systems.
Ability to create and analyze meaningful metrics.
Comp e tencies:
Professional Knowled g e
Problem Solving
Team Player / Building Relat i onships
Multi‐tasking
Customer F o c u s
Acti o n and detail orient e d
Active Listen i n g
Decisive
Educat i on & Expe r ienc e :
BS in Engineering or Science related discipline preferred.
Minimum of 5 years' experience in FDA-regulated industry.
Minimum of 5 years' experience managing personnel and/ or projects.
Strong instrumentation background and experience in laboratory and manufacturing operations.
Knowledge of cGMP in the pharmaceutical industry.
Excellent computer skills including knowledge of calibration management and environmental monitoring systems
Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
Experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions.
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
3 years of managing direct reports.
Working Conditions:
Physical / M e ntal Dema n ds:
Occasional st o opin g , b end i n g , stretching, pushing, pulling, reach i ng and/or lifting up to 25lbs
Ability to sit, s t and, walk a nd move within w orkspace for e xtended peri o ds
Ability to per fo rm repetitive t a s ks including hand to finger manipulati o ns, grasping, pushing a nd pulling. Environmental Conditions:
Primarily office environment, but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
Ability to work safely a nd ef f ectively whe n working al o ne, or working wit h others.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 the resources to pursue their goals, both at work and in their personal lives. Company:****
R1523828_EN Updated:
2020-04-02 00:00:00.000 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.

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