Bristol-Myers Squibb Company

QA Validation Analyst

Location
Syracuse, NY, United States
Posted
May 23, 2019
Ref
R1514701
Required Education
Bachelors Degree
Position Type
Full time
Responsible for the validated state of the equipment, instruments and automation in manufacturing facilities. Ensures that all Regulatory and cGMP compliance items are satisfied.

Will have and provide quality oversight on the validation of equipment, instruments and automation in the manufacturing facility and laboratories. Will have and provide quality oversight on the validation of process utilities.
  • Quality Lead on installation qualification, operational qualification and performance qualification protocols and reports for equipment, instruments and automation in manufacturing facility.
  • Quality Lead on process characterization and qualification protocols and reports.
  • Demonstrates track record of developing and implementing logical and optimal plans to achieve objectives. Develops practical solutions to significant challenges.
  • Provides credible output with little or no direct supervision. Able to identify opportunities for realistic improvements within project scope.
  • Significantly leads or contributes to the creation of team based, collaborative environment promoting candor and receptivity, clarity of purpose and goals, and high commitment to achieve business goals.
  • Develop and communicates expertise in areas beneficial to group/project focus area.
  • Identifies issues within and outside area of responsibility. Evaluates options and presents solutions to manager. Leads cross functional efforts to implement solutions.
  • Will be expected to cross train and develop their expertise in other areas of validation, such as analytical instruments, method validation, process validation, etc.

Work with functional team to develop comprehensive inventory of systems and process and their qualification status.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

  • Personnel must have extensive knowledge and experience of any of the following is required: operation and validation of processing equipment, operation and validation of process control systems (DCS and PLC), operation of process utilities (WFI, HVAC, steam air) and process knowledge of mammalilan cell growth, chromatography and filtration of proteins or aseptic processing.
  • Personnel must have extensive knowledge and experience in computer systems validation.
  • Must have effective verbal and written communication skills.
  • Must demonstrate multitasking and organizational skills.
  • Must be able to interact and lead effectively in a team based environment.
  • Attention to written detail is essential.


Education/Experience/ Licenses/Certifications:

Bachelor of Science in Microbiology, Biotechnology, Chemical Engineering or scientific field having with 8+ years experience in pharmaceutical manufacturing of biologics or aseptic filled products. (or a MS with 5-7 years relevant experience).