ASSOCIATE ENGINEER I

Employment Type

: Full-Time

Industry

: Miscellaneous



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.

POSITION SUMMARY:

The Manufacturing Technology Associate Engineer will support Manufacturing Operations (Downstream processing, column packing) on a daily basis, as well as lead or contribute to strategic projects

Duties/Responsibilities:

Support projects and identify opportunities for productivity, robustness, quality, business process, and safety improvements.

Regular and frequent on-floor observation to support and improve manufacturing.

Collect process data, perform statistical analysis and identify opportunities for improvement of process performance.

Support process-related Quality Investigations to determine root cause, assess product impact and determine CAPA.

Originate, review and evaluate change controls.

Support PPQ and BLA filings including on-floor support, data verification and data analysis.

Support technical transfer of new molecules, perform facility fit and lead implementation of product/process transfers between manufacturing facilities.

Author protocols and final technical reports for requested initiatives/ studies.

Review manufacturing batch records (MBR), standard operating procedures (SOP), and other cGMP documentation, as required.

Follow cGMP requirements.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

- The candidate must have demonstrated verbal, written, and communication skills and a successful proven history of working with technical teams.

- Technical writing ability a must.

- Experience with manufacturing support or technical transfer preferred

- Experience with statistics and SPC preferred

Education/Experience/ Licenses/Certifications:

- BS with 2+ years experience or a MS with 0-2 years experience required. Degree in Engineering field (e.g. Chemical, Biological) or relevant biotechnology coursework strongly preferred.

- Experience should include technical support of cGMP/Biologics facility (R & D, technology transfer, manufacturing).

Physical Demands:

This position is primarily an office-based role and requires repetitive use of hands and wrist (computer work), and infrequent lifting of items not to exceed 50 lbs. Occasional bending, twisting and stooping to allow for gowning into classified environment required.

Work Environment:

This position is primarily office based with occasional work in a classified GMP manufacturing environment. Work will take part both individually and as part of a group.

Travel:

- This position requires up to 5% of travel

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.

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