Job was saved successfully.
Job was removed from Saved Jobs.

Job Details


Bristol Myers Squibb

Manager, Quality Assurance, Environmental QA

Technology

Quality Assurance

Yearly

No

Bothell, Washington, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Purpose and Scope of Position:

The Quality Engineering and Validation team at BMS is responsible for providing Quality Assurance oversight of environmental, equipment, utility and facility, maintenance, process validation and engineering documents, test protocols, CAPAs, deviations, change control records, and additional site based technical documentation and activities.

The position of Manager, Quality Engineering and Validation is responsible for providing Quality oversight to the QC Microbiology Department.

Education:

Bachelor’s degree in a STEM discipline, additional disciplines may be considered if combined with relevant experience

Experience

  • Minimum of 7 years working in a Quality, Engineering, Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization.
  • Experience in cleanroom qualification, pharmaceutical microbiology, and contamination control strategies.
  • Direct experience with providing cleanroom guidance and support in a commercial biopharmaceutical, cellular therapy, or gene therapy organization required.

Knowledge, Skills, and Abilities

  • Knowledge of cGMP regulations, FDA, EMA and PMDA guidelines applicable to biologics and cell therapy.
  • Knowledge of cleanroom microbiology, pharmaceutical cleaning, environmental controls, aseptic process simulation, EMPQ, and QC program requirements.
  • Strong individual contributor with demonstrated ability to work independently.
  • Basic understanding of microbiological investigations including familiarity with commonly identified organisms, sources, and vectors.
  • Excellent communication, trouble shooting, and problem-solving skills.

Key Responsibilities

  • Mentor and be a resource for 1-3 junior coworkers or contractors
  • Provide Quality oversight of cleanroom environmental control programs and of the QC Microbiology department. Scope includes but is not limited to environmental monitoring (EM), cleaning and sanitization, and facility controls, validation studies, continuous improvement, and compliance projects.
  • Review and approve complex documentation in support of GMP operations, including but not limited to facility plans, technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.
  • Serve as a site SME on Pharmaceutical Microbiology and Cleanroom Practices. Maintain current awareness of technical reports, regulatory changes, and industry standards and advise the department accordingly.
  • Proactively identify and resolve technical and compliance issues/gaps, may lead improvement projects.
  • Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility and process knowledge.
  • Ensure adherence to internal procedures and industry/regulatory expectations

WORKING CONDITIONS (US Only):

  • Equipment Usage During Work Period: Computer 80%; Phone and Electronic Devices 20%.
  • Sitting at a computer terminal for an extended period of time.
  • Regular sitting, standing, talking, listening, using hands & fingers to operate a computer and telephone
  • Requirement to work in a conference room / meeting environment for moderate periods of time.
  • Occasional periods in labs or production area, requiring some level of gowning.
  • Light to moderate lifting.
  • Regular, predictable attendance is required. Occasional overtime, as business demands dictate.
  • Moderate noise i.e. business office with computers, phone, and printers.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.