Assistant Validation Engineer
Devens , Massachusetts
January 05, 2017
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.

Ensure the maintenance of the validated state for equipment, facilities, critical process utility systems and manufacturing computerized systems which support clinical and commercial manufacturing facilities. Manage and execute the installation qualification, the operational qualification and the performance qualification (IQ/OQ/PQ) of process equipment, the validation of SIP / CIP processes, validation of changes to manufacturing computerized systems and critical process utility systems to assure readiness for intended use to meet policy and compliance requirements.

Duties and Responsibilities:
· Executes with guidance from validation leads or management validation efforts associated with the operation of GMP manufacturing systems including installation, operational and performance qualification (IQ/OQ/PQ) of area specific process equipment, validation of SIP/CIP processes, qualification of environmental chambers and qualification of critical process utility systems.
· Execution of testing of required changes to the site Process Automation System (Delta V) - Execution of testing of process recipes for the Manufacturing Execution System (Syncade)
· Performs assessment of validation work arising from change controls, capital projects, shutdown/changeover activity and ongoing revalidation programs with support from department management.
· Technical work assignments and interfaces with project stakeholders.
Maintains familiarity with BMS directives and industry guidelines on qualification/validation.

Knowledge and Skill:
· Familiarity with or interest in distributed control systems and automation (GAMP) validation concepts may enable this individual to participate in cross-functional validation efforts.
· Excellent project management, communication, and technical writing skills are required.
· Demonstrated effectiveness in both a team environment and an individual contributor role.

• Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical or mechanical preferred), a related discipline, or its equivalent is required.
• Co-op or internship experience in biopharmaceutical industry including experience with manufacturing equipment support in the Biotechnology manufacturing industry is desired.
• Familiarity with or interest in process equipment and system qualification, sterilization qualification, critical utilities validation, cleaning validation, and temperature mapping concepts is desired.

This position supports 24/7 manufacturing facility. The selected candidate must be available to work a flexible schedule to support business operations. Work schedule may change to cover second-shift, weekend and holidays.

A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.

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