Manager, Validation Services

Job Responsibilities:

The Validation Services Manager is responsible for the strategic and technical
direction of the Validation Services group within the Bioprocess Engineering
Department. The successful candidate will support the Bristol Myers Squibb
Companys biotechnology manufacturing organization by ensuring the development
and execution of process support validation, cleaning validation, CIP and
equipment and facility qualification, IQ, OQ, PQ and SIP, studies. The
Validation Services Manager will supervise a multifunctional staff of
approximately 15 full time and contract individuals. In addition, the candidate
will identify additional opportunities within the manufacturing facility to
leverage the resident technical expertise of the group, make formal
recommendations to address these opportunities and drive the recommendations to
completion. The candidate will be expected to mentor and develop staff within
Validation Services. The candidate will also provide technical support in
generating regulatory responses and submissions. The candidate will be expected
to interact with domestic and international regulators as required.

Job Requirements/Education:

The candidate must have a BS or MS in Engineering or Biological Sciences or
Chemistry and 5 to 10 years of relevant validation experience. The candidate
must have demonstrated verbal, written, and presentation skills and have a
successful record of managing validation personnel and projects. The candidate
should have relevant regulatory experience, including the preparation of
regulatory submissions and responses and interactions with federal and
international regulators.

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