Sr. Automation Validation Engineer

Profile

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.

Responsibilities:

The Sr. Automation Validation Engineer performs computer system validation on configuration of the Process Control System (DeltaV) and Manufacturing Execution System (Syncade) which support clinical and commercial manufacturing facilities. This role manages protocol generation, test execution, issue resolution and approval of qualification efforts to assure readiness for intended use to meet policy and compliance requirements.

Leads the validation efforts associated with the operation of all GMP manufacturing systems (Process Automation System, Manufacturing Execution System) in a highly automated biologics manufacturing facility.

Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Process Automation System (Delta V).

Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Manufacturing Execution System (Syncade).

Executes and/or leads validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs.

Develops appropriate validation methodologies in collaboration with Operations management and Quality Assurance for novel projects.

Leads a portfolio of validation projects under strict deadlines to ensure stakeholder success and bulk drug supply.

Executes and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.

Provides validation subject matter expertise (SME), to multi-function teams, advises operations on validation matters, and defends their work before regulatory agencies.

Ensures alignment with BMS directives and industry guidelines on validation.

Duties may include internal compliance or efficiency improvement efforts within department.

Knowledge and Skill

Specific technical skills with biopharmaceutical processing including a minimum of 6 years experience developing and/or testing process automation system software (preferably Delta V batch). Understanding of S88 and batch processing operations required. Practical experience with large scale distributed control systems required.

Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent.

Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.

Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.

Comprehensive DCS and PLC based experience, preferably gained in the pharmaceutical industry.

Knowledge of procedural batch processing automation in a Delta V environment.

Knowledge of a system life cycle validation techniques for automation software specification and development.

Familiar with construction techniques and automation system hardware installation practices.

Experience with dealing with recognized large automation providers (Emerson, Rockwell preferred).

Familiarity with distributed control systems and automation (GAMP) validation concepts allows this individual to participate in cross-functional validation efforts. A working understanding of lean principles is a suggested.

Demonstrated proficiency in project management, oral communication, and technical writing skills are required.

The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.

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.

Company: Bristol-Myers Squibb

Req Number: R1521356_EN

Updated: 2020-02-02 00:00:00.000 UTC

Location: Devens,Massachusetts

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com