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Location
Bothell, WA, United States
Posted on
Jun 25, 2020
Profile
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 Manufacturing Associate III (MAIII) is a seasoned and experienced associate who leads and drives the execution of manufacturing processes according to established electronic work instructions and production records for the manufacture of cell therapies with Current Good Manufacturing Practices (cGMP's). A MAIII is responsible for aiding in driving of a team whose primary focus is on execution of manufacturing processes within their functional group on the manufacturing floor. A MAIII is required to provide their direct team members with knowledge and technical knowledge for troubleshooting activities.
DUTIES AND RESPONSIBILITIES:
Works on routine manufacturing assignments per written procedures, where ability to recognize deviation from accepted practice is required.
Adheres to Good Manufacturing Practices and standard operating procedures.
Measures and checks raw materials. Assembles, cleans and sanitizes process equipment and or assemblies.
Completes work instructions and maintains clean room environment to comply with regulatory requirements.
Trains for and ensures team members are proficient in the operation of primary production equipment within the assigned functional area.
Is a subject matter in process systems (i.e. Syncade MES and Oracle interfaces) and some supporting business systems (i.e. Oracle, ETQ, BMRAM etc.).
Own revisions and or creation of process documents, such as SOPs and electronic work instructions as well as workflow ownership in document management systems.
Leads in maintaining material and components inventory level.
Supports safe work environment and provides assistance for areas specific initiatives associated with work safety.
Work in teams and have continual interaction with members of his/her team as well as other manufacturing teams throughout the production process in order to exchange information regarding the batch(s) in process.
Works on assignments that are routine in nature where judgment is required in resolving problems and making routine recommendations.
Drives right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving.
Aids in daily work coordination and distribution as demanded through the production schedule.
Is responsible for maintaining schedule adherence and cycle time. Reports variances and communicates impact to cross functional groups and supervisors.
Provides shift handover and tier three communication working with other shift team members.
Ensure shift notes communication is complete and accurate.
Provide daily update summary for inbound and outbound shift members within responsible functional group for SQDCP.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education:
Associate's or Bachelor's degree in related field is preferred. Minimum of high school diploma and/or equivalent combination of education and experience is required.
Experience
3-6 years of relevant manufacturing experience. Peer level on the floor lead experience which demonstrates proficiency and compliant schedule adherence is highly desired. Extensive knowledge of SOPs and cGMPs and the know-how to work and manage within a regulatory environment. Demonstrates aptitude for engineering principles and manufacturing systems. Adaptable to a fast paced, complex and ever-changing business environment.
WORKING CONDITIONS (US Only):
Must be able to work in a cleanroom environment that requires gowning.
Must be able to stand for extended periods of time.
Required to carry and/or lift to 30 pounds several times a day while handling production equipment and/or materials.
Required to push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials
Work in areas that may have strong magnets.
Work in areas where handling human blood products (Biosafety Level 2) may be required.
May work in areas with exposure to vapor phase liquid nitrogen.
Must be able to work nights, weekends, mandatory bi-weekly overtime and holidays in a 12-hour shift structure.
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.
Company: Bristol-Myers Squibb
Req Number: R1526830_EN
Updated: 2020-06-24 00:00:00.000 UTC
Location: Bothell,Washington
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.
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