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 Validation Engineer, Equipment Commissioning & Qualification (ECQ) supports the successful implementation and support of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses strong analytical skills to recognize and solve common problems of various degrees of complexity and 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 Lead Validation Engineer, through hands-on leadership, will be directly responsible for individual and team based efforts, projects and other tasks. The incumbent will be responsible for fostering a productive, learning environment for colleagues and reports while ensuring timely completion of assigned work.
Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures:
Supports equipment qualification and validation activities.
Investigate and resolve Deviations, CAPA investigations and other potential issues.
Configure and document the configuration of computerized systems to meet the requirements of CFR21 Part 11.
Supports the execution of equipment qualifications and validation protocols
Supervises vendors for qualification functions.
Completes all qualification and validation documentation with accuracy, completeness and compliance to Celgene standards.
Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.
Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
Initiates, manages and leads projects of moderate scope and complexity within their functional area.
Supervise and direct other team members to ensure completion of objectives.
Manages projects of varying scope and complexity.
Maintains a positive relationship with all team members and site customers while promoting a positive learning, team environment.
Author quality procedures and training documents
Deliver training on procedures and best practice to an audience that may include departmental personnel and business partners.
Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment.
Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
Support growing standardization efforts in the review and approval of Validation Deliverables
Promotes and provides excellent customer service and support
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 Validation, Quality Process and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
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 degree or equivalent experience
Minimum 5 years of experience in FDA-regulated industry
Knowledge, Skills & Abilities:
Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance
Strong working knowledge of SDLC principles and standards
Ability to work with the end user to identify and document User and Functional Requirements
Knowledge of pharmaceutical laboratory and manufacturing systems.
Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groups
Strong working knowledge of MS Windows client and server technologies.
Strong 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
Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation
Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.
Technical / Professional Knowledge
Problem Solving / Troubleshooting
Attention to Detail
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 an office 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.
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.