ECQ Engineer

Posted:
9/30/2024, 11:11:12 AM

Location(s):
New Jersey, United States ⋅ West New York, New Jersey, United States ⋅ Summit, New Jersey, United States

Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior

Field(s):
IT & Security

Workplace Type:
Hybrid

Working with Us
Challenging. 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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Equipment Engineer, Equipment Commissioning & Qualification Operations supports the successful operation of laboratory, clinical and commercial 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.

Shifts Available:

Quad 1 - Sunday - Every Other Wednesday, 5am - 5:30pm

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.    

Regulatory Responsibilities

  • Maintains all required Corporate, Facilities and EHS training as required.
  • Adheres to all safety procedures and hazard communication.   
  • May be called upon to act as SME in both internal and regulatory audits.

Knowledge & Skills:

  • 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.  
  • 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 Facilities groups.

Basic Requirements:

  • BS in Engineering or Science related discipline preferred.
  • Minimum 2 years’ experience in FDA-regulated industry

Preferred Requirements:

  • Experience working directly with bench top manufacturing and laboratory equipment (cell counters, liquid handlers, Flow Cytometry, etc.) preferred.
  • 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 commercial environment preferred.

 
Working Conditions:

Physical / Mental Demands:

  • Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs
  • 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:

  • Will likely spend >70% of their time in a laboratory or manufacturing environment.  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.

BMSCART

#LI-ONSITE

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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