Equipment Engineer Equipment Commissioning and Qualification ECQOperations

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Bristol Myers Squibb
Equipment Engineer, Equipment Commissioning and Qualification (ECQ)Operations
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 Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home site through interaction with internal team members and internal customers as well as external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization. The incumbent may be asked to lead small to medium sized projects in their area of responsibility and will be called upon to create and revise work processes or procedures that impact their immediate function or organizational unit. The incumbent will be involved with writing deviations, investigations and supporting the implementation of change controls.
DUTIES AND RESPONSIBILITIES
Operational Activities
Executes equipment calibration, preventative maintenance, performance verification and repair activities in both laboratory and manufacturing areas.
Supervises vendors for calibration, preventative maintenance, performance verification and repair functions.
Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, completeness and compliance to Bristol-Myers Squibb standards.
Works closely with and enters data into the site CMMS system.
Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
Writes and supports deviations and investigations that result from calibration or performance verification failures along with developing and supporting the implementation of corrective and preventative actions.
Support the development, revision and review of written procedures for calibration, preventive maintenance and performance verification of equipment.
Support the development, review and approval of calibration and maintenance plans in site CMMS system.
Supports the execution of equipment performance verification and process improvement studies.
Adheres to all policies and procedures which govern the ECQ team and the equipment they manage in order to ensure compliance is held to the highest standard.
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.
Inventory Management
Work with planning group to ensure system is updated as calibration, maintenance and performance verification 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.
Regulatory Responsibilities
Ensure equipment maintenance programs are maintained in compliance.
Adheres to all safety procedures and hazard communication.
May be called upon to act as SME in both internal and regulatory audits.
REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities
Knowledge, Skills & 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.
Understanding of scheduling fundamentals and execution.
Strong written and verbal communication skills.
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. 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, mainly Blue Mountain RAM.
Ability to interact effectively with laboratory, QA and Facility groups.
EDUCATION AND EXPERIENCE
BS in Engineering or Science related discipline preferred.
Minimum 2 years' experience in FDA-regulated industry
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.
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
2 years of maintenance coordinating / planning experience, preferably in a laboratory environment.
Experience working in a clinical environment preferred.
WORKING CONDITIONS (US Only):
PHYSICAL/ MENTAL DEMANDS (US Only):
Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25 lbs.
Ability to sit, stand, walk and move within workspace for extended periods
Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and 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 and effectively when working alone or working with 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 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:****
Req Number:
R1526362_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.

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