Associate Manager Equipment Commissioning and Qualification ECQ Delivery

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Job Information

Bristol Myers Squibb

Associate Manager, Equipment Commissioning and Qualification (ECQ) Delivery

in

Warren

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.

PURPOSE AND SCOPE OF POSITION:

The Associate Manager, Equipment Commissioning & Qualification Delivery supports the successful operation of facility, laboratory and business functions at multi‐use sites through interaction with internal team members and peer‐level customers as well as external service providers. The incumbent in this role supervises entry, junior, and experienced level professionals to accomplish daily tasks and short‐term projects according to established policies and procedures. The individual manages multiple projects and ongoing work activities of low to moderate complexity to ensure on time completion. In addition to answering questions and resolving issues for staff, the incumbent spends a small portion of their time on individual work. The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit.

DUTIES AND RESPONSIBILITIES

Management Responsibilities

Lead a team of up to 10 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.

Set goals for and deliver personnel performance reviews for direct 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 company 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.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities

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 cell therapy clinical manufacturing.

Ability to develop, delegate and motivate others including direct and indirect reports.

Understanding of scheduling fundamentals and execution.

Strong written and verbal communication skills.

Excellent interpersonal skills with experience dealing with a diverse workforce.

Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. 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.

Working knowledge of scheduling software and systems, and inventory management systems.

Ability to create and analyze meaningful metrics.

Competencies:

Professional Knowledge

Problem Solving

Team Player / Building Relationships

Multi‐tasking

Customer Focus

Action and detail oriented

Active Listening

Decisive

EDUCATION AND EXPERIENCE

BS in Engineering or Science related discipline preferred.

Minimum of 5 years of experience in FDA-regulated industry.

Minimum of 5 years of 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: (US Only)

PHYSICAL /MENTAL DEMANDS: (US Only)

Occasional st o opin g , b end i n g , stretching, pushing, pulling, reach i ng and/or lifting up to 25 lbs.

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: (US Only)

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.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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:

Bristol-Myers Squibb

Req Number:

R1526351_EN

Updated:

2020-06-10 00:00:00.000 UTC

Location:

Warren,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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com