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 of the Position:
The Lead 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.
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 for computerized and non-computerized equipment, 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.
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:
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
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.
Team Player / Building Relationships
Action and detail oriented
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.
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.
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.