Associate Director, Validation Services
Company: Bristol-Myers Squibb Company
Posted on: August 16, 2019
Major Duties & Responsibilities1. Lead the qualification/validation
function for a fully automated commercial Biologics Drug Substance
manufacturing facility.2. Lead functions within the Validation
group responsible for installation, operational and performance
qualification (IQ/OQ/PQ) of process equipment, validation of
SIP/CIP processes, validation of critical process equipment &
utility systems and validation of process automation systems.3.
Oversee validation execution for all engineering projects (small to
large). Establish validation project plans commensurate with the
level of risk and manage the execution of validation projects whose
scope, regulatory visibility, schedule requirements, and complexity
require coordination with customers, collaborators, and quality.4.
Owns the overall Site Validation Master Plan.5. Responsibilities
include oversight of validation execution work arising from change
controls, capital projects, shutdown/changeover activity, and
ongoing revalidation and cleaning monitoring programs. This
individual works in conjunction with Quality Assurance to establish
appropriate plans and strategies aligned with site validation
philosophies.6. Responsible to deliver validation projects under
strict deadlines to ensure customer success and bulk drug supply.
This includes the establishment of plans, protocols, test scripts,
risk assessments, and summary reports.7. Manage multiple projects
while serving as a point of contact for validation execution
projects.8. Responsible to act as a validation subject matter
expert (SME), serving as the primary point of contact to present
validation philosophies and strategies to Health Authority
inspectors and auditors.9. Works collaboratively with
Manufacturing, Technical Manufacturing, Manufacturing Technology,
Facilities & Engineering and Quality.10. Effectively manages
assigned resources to address priorities, meet schedules, maximize
productivity, reduce costs, and increase efficiencies.11. Ensure
alignment with BMS directives and industry guidelines on
validation.12. Develops and leads a high performance team
responsible for validation execution, manages the recruitment and
development of staff, invests in the development of current and
future leadership through assignment of development opportunities,
coaching, mentoring, and effective administration of rewards and
recognition.13. Establishes and communicates high performance
standards, defines clear accountability, and leads by adopting
continuous improvement strategies to reduce operational variances
and reduce cycle time.14. Responsible for ensuring all regulatory
and GxP compliance items related to Validation are satisfied.15.
Provide significant regulatory inspection readiness training,
coaching and guidance to junior level staff/SMEs in validation
group.16. Manage and develop staff, establish a staffing plan that
includes adequate competent resourcing, hiring of key technical
individuals as needed, and development and succession
planning.Knowledge and Skills
- Knowledge of Engineering and Quality Assurance generally
attained through studies resulting in a B.S., in engineering, a
related discipline, or its equivalent and applicable industry
- A minimum of 12+ years directly relevant experience in
validation of process equipment, computer systems, manufacturing
process control systems (automation) and laboratory instrumentation
in a biologics drug substance manufacturing facility.
- Direct experience with sterilization qualification, cleaning
validation, critical utilities validation, cleaning validation,
computer validation and temperature mapping concepts is
- Previous managerial experience which demonstrates proficiency
in selection, motivating and retaining a superior team, effectively
managing personnel issues and planning and administering financial
- Experience with Health Authority Inspections, External
Auditors, Corporate and Internal Auditors presenting validation
philosophies, strategies and executed testing.
- Familiarity with distributed control systems and automation
(GAMP) validation concepts allows this individual to participate in
cross-functional validation efforts.
- A working understanding of lean principles is preferred.
Excellent project management, communication, and technical writing
skills are required.
- The successful candidate will possess the professionalism and
technical competency required to represent the department before
our customers, regulatory agencies, and management.
- Demonstrated understanding of engineering documentation such as
P and IDs, Process Flow diagrams and Standard Operating
- Knowledge of regulatory validation requirements including FDA,
EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8,
and Q9) particularly as it applies to biologics manufacturing.
- Proven ability working in a matrix environment and leading
multi-level / cross functional teams to achieve the highest
performance in meeting site and departmental objectives.ContactsThe
Associate Director, Validation Servicesis in direct contact with
the Director, Facilities & Engineering, and other senior leaders
within the site, including heads of Quality, Manufacturing, Supply
Chain and Human Resources. Frequent interactions occur with
Qualityand Manufacturing staff.Occasional interactions occur with
external industry and regulatory representatives.Will interact
directly with Health Authorities during inspections to explain
validation related inquiries, as required.This position is largely
self-directed, receiving high-level goals from incumbent's
supervisor. This position exercises considerable latitude in
execution of responsibilities and tasks. The incumbent must make
decisions independently and demonstrate flexibility to balance
shifting priorities while handling large increases in work
load.This position will supervise a team of validation engineers,
scientists and in some cases contract technicians in the
development, execution and summary report writing of validation
protocols, test scripts, master plans, risk assessments etc. The
Department will consist of both full time and contract resources (n
= 10 to 12 - in normal circumstances). Number will vary based on
number of projects in progress.
Keywords: Bristol-Myers Squibb Company, Syracuse , Associate Director, Validation Services, Executive , Syracuse, New York
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