QA COMPUTER VALIDATION SPECIALIST

Job Responsibilities:

Perform review and approval of computer validation protocols and reports.
Ensures that all Regulatory and cGMP compliance items related to Computer
Validation are satisfied. This role may also serve as a backup to other
Validation Specialists when the need arises. This position requires independent
decision making. Decisions are also made in conjunction with Biotechnology and
other key QA personnel. Significantly contributes to the creation of a team
based, collaborative environment promoting candor and receptivity, clarity of
purpose and goals, and high commitment to achieve business goals. Demonstrates
appropriate examples for compliance behaviors and attitudes, thereby Shaping
the Culture. Will meet and exceed all Safety expectations and adhere to all BMS
Core behaviors.

Job Requirements/Education:

This position requires a Bachelors degree in Chemical Engineering, Computer
Science or in a related discipline. M.S. degree is preferable. Also required is
minimum experience of 3 to 8 years in QA, Validation, Production environment,
Information andor QC operations. Personnel must have excellent working
knowledge of cGMPs as they relate to the role of computers in manufacturing and
laboratory operations. Knowledge and experience of any of the following is
expected operation and validation of process control systems DCS and PLC,
computer systems related to analytical instrumentation, Part 11 requirements,
and mainframe systems LIMS, SAP, Millennium. In addition, knowledge and
experience with process, utility and equipment validation, sterilization and
cleaning validation, cell culture and purification operations as well as
analytical characterization of proteins isdesirable in order to fill backup
roles. Personnel must have excellent oral and written communication skills,
demonstrated multitasking and organizational skills, and proven ability to
interact effectively in a team based environment. Attention to written detail
is essential, as well as the ability to establish andor lead critical
Validation teams to achieve specific goals.

Salary will be commensurate with experience.
Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D