Sr. Specialist, Manufacturing

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

Day shift- flexible-8am- 5pm or 6am-2pm , 7am-3pm.

Education and Experience

• Relevant college or university degree preferred

• 5 years relevant work experience required, preferably in a pharmaceutical environment.

• An equivalent combination of education and experience acceptable.

Required Competencies:  Knowledge, Skills, and Abilities

• Intermediate proficiency in MS Office Suite applications.

• Intermediate knowledge of cGMP for a controlled manufacturing area.

• Intermediate trending analysis skills to include compilation, sorting and reporting

• Intermediate understanding of Validation concepts and principals.

• Advanced critical thinking and decision making skills.

• Advanced time-management, organizational, and multi-tasking abilities

• Advanced written and verbal communication skills.

  • Ability to solve routine and complex problems.

  • Ability to interpret / write technical documents.

• Ability to work independently for extended periods of time.

  • Ability to lead a cross-functional, technical team to support site/departments projects.

  • Ability to conduct and document deviation investigations and change controls.

Duties and Responsibilities

Provides support to Manufacturing Operations within the appropriate GMP system.

• Deviation/Investigation

• CAPA

• Change Control

• Protocol

• SOP revision/creation

• Works with Manufacturing Management to ensure compliance with cGMPs, SOPs and policies.

• Collaborates with Manufacturing Management to support/lead initiatives to improve the manufacturing process.

• Lead cross functional investigative teams deploying specific investigative principles as necessary to ensure root cause analysis and corrective action(s)

• Ensures corrective actions and improvements are shared and incorporated into the appropriate process.

• Provides feedback to Manufacturing Management and support groups in relation to findings during deviation investigations.

• Generate, manage and execute CAPA and Change Control documents to support response to deviations, audit findings and independent corrective actions.

• Generate and execute change notice to support SOP, Work Practice and Program revision and maintenance.

• Compile department and site trending information for evaluation.

• Develop, implement and maintain applicable department/site programs.

• Serve as an SME for various systems during internal, external and regulatory audits.

• Performs all other tasks as assigned.

Working Conditions

• Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 20% of the time.  

• Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

• The incumbent must be able effectively communicate deviation/investigation results to the senior leadership within the site on a weekly basis.

• The incumbent must be able to gown to Grade A, B, C and D requirements. This requires the ability to bend and move to gown aseptically.

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