Bristol Myers Squibb Company

Lead Validation Engineer, Equipment Commissioning & Qualification (ECQ)

Location
Celgene, NJ, United States
Posted
Aug 29, 2020
Ref
R1523828
Required Education
Bachelors Degree
Position Type
Full time
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 of the Position:

The Lead Validation Engineer, Equipment Commissioning & Qualification (ECQ) Delivery supports the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, identifies issues or unmet needs and initiates projects or programs to address them. This individual works independently to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently, develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge.

Essential Functions:

Maintains all qualified equipment systems in compliance with policies, guidelines and procedures:

Develops and approves change controls, validation plans, qualification protocols, associated reports and procedures.

Executes equipment qualifications, validation protocols, and process improvement studies.

Schedules and performs periodic field review of qualified systems

Conducts investigations into qualification failures, and develops and implements remediation plans

Contracts with and supervises vendors for qualification and metrology functions.

Provides guidance and reviews written procedures for calibration and preventive maintenance of equipment

Mentors and trains validation specialists and operations personnel in calibration, equipment qualification and validation techniques.

Initiates, manages and leads projects of moderate scope and complexity within their functional area.

Manages equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.

Provides guidance to internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.

Supports facilities new construction and relocation projects.

Reviews all calibration, qualification and validation documentation for accuracy, completeness and compliance to Celgene standards.

Provides technical knowledge and direction as Equipment Commissioning & Qualification site representative during interactions with all cross functional groups, as required.

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.

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, Skills & Abilities:
  • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
  • Experience in the qualification of cell therapy equipment a plus.
  • Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
  • Ability to develop, delegate and motivate others including direct and indirect reports.
  • Understanding of scheduling fundamentals and execution.
  • Strong written and verbal communication skills.
  • Experience writing and executing equipment qualification documents
  • 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. Innate ability to learn new software, such as corporate intranet and enterprise business.
  • Working knowledge of scheduling software and systems, and inventory management systems.


Competencies:
  • Professional Knowledge
  • Problem Solving
  • Team Player / Building Relationships
  • Multi‐tasking
  • Customer Focus
  • Action and detail oriented
  • Active Listening
  • Decisive


Education & Experience:
  • BS in Engineering or Science related discipline preferred.
  • Minimum of 5 years' experience in FDA-regulated industry. with 5 years experience in equipment qualification.
  • Knowledge of cGMP in the pharmaceutical industry.
  • 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


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:

• 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.

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.