Sr. QA Specialist, Quality Engineering

Location
Bothell, WA, United States
Posted
Sep 23, 2020
Ref
R1529698
Required Education
Bachelors Degree
Position Type
Full time
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.

About Bristol-Myers Squibb

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 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, and process validation and engineering documents, test protocols, CAPAs, deviations, change control records, and additional site based technical documentation and activities. The position of Sr Engineer reports to the Manager, Quality Engineering and Validation. This position is based at the BMS Manufacturing Plant (JuMP) located in Bothell, WA.

Basic Qualifications Required
  • Bachelor's Degree in Life Science or Engineering
  • MS Preferred
  • 7+ yrs experience in a GMP Quality, Engineering or Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization.

Experience:
  • Dirrect experience with providing Quality Engineering guidance and support in a commercial biopharmaceutical, cellular therapy, or gene therapy organization strongly preferred.
  • Experience with Process Validation in a biopharmaceutical environment.
  • Experience in Systems related to validation, calibration, maintenance, change control, and deviations strongly preferred.


Knowledge, Skills, and Abilities
  • Knowledge of cGMP regulations, automation standards, FDA, EMA and PMDA guidelines applicable to biologics and cell therapy.
  • Strong individual contributor with demonstrated ability to work independently.
  • Experience in developing/optimizing Quality Systems related to validation, calibration, maintenance, change control, and automation strongly preferred.
  • Excellent communication, trouble shooting, and problem-solving skills.


Key Responsibilities
  • Provide Quality oversight of process validation studies and process performance qualifications.
  • Provide oversight of cleanroom environmental programs including environmental monitoring (EM), cleaning and sanitization, and facility controls.
  • Review and approve complex documentation in support of GMP operations at JuMP, including but not limited to facility plans, validation and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.
  • Proactively identify and resolve technical and compliance issues/gaps.
  • Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge.
  • Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations - calibration/maintenance, shutdowns, construction projects, etc.).
  • Collaborate with stakeholders within and outside of the JuMP Manufacturing Facility, and communicate equipment, facility and system status; monitor progress and issue status reports.
  • Act as Quality Engineering Subject Matter Expert for responsible areas/projects during regulatory inspections.


WORKING CONDITIONS (US Only):
  • Equipment Usage During Work Period: Computer 70%; Phone and Electronic Devices 30%.
  • 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 keyboard reach.
  • 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, plus 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.

BMSCART

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.