Sr. Validation Engineer
Victor Greer
This position requires a bachelors degree or higher in Science,
Engineering, or related discipline. An advanced degree and ASQ
certification are a plus. Typical experience for this position would
be a least 8 years in laboratory computer related system
administration and validation of laboratory instrumentation, and with
over 10 years in a cGMP environment. Candidates should demonstrate an
in-depth knowledge of validation processes and programs, familiarity
with pharmaceutical or biotech processes, and familiarity with
documentation in a highly regulated environment.
Additional requirements include the ability to operate specialized
laboratory equipment and computers, interpret and apply GMP, GLP and
GCP and CFR Part 11 regulations, as well as the ability to apply
validation engineering to research, development and manufacturing, and
develop solutions to routine technical problems. Candidate should
also have knowledge of theories and principles related to leading edge
technologies, be an advanced technical expert in analytical laboratory
systems, in addition to having the ability to motivate and
communiciate vision and direction of validation programs and influence
validation programs at a site and corporate level.
Job Summary:
Support system validation projects in the quality analytical
laboratory (QAL) facilities, including analytical instrumentation,
laboratory equipment, and laboratory data management systems
throughout Amgen. Provide expert quality and compliance solutions to
system users and validation staff. Also, support lab validation at
Amgen sites in a cross-functional team environment. Responsible for
establishing validation engineering policies, interpreting, executing,
and/or recommending modifications to company-wide policies, and
developing organizational budgets or project budgets encompassing all
disciplines for large or complex projects. Solid experience and
knowledge of analytical laboratory hardware and software, GPL, GCP,
and CFR Part 11 requirements for computer related systems, and
technical writing skills required.
This position also requires outstanding communication skills,
including the ability to set managerial context for the work assigned
and the ability to communiciate effectively with customers. Excellent
planning and organizational skills required. The position requires
experience and the flexibility to deal with people at a variety of
levels; from senior Managerial staff to individuals users. This
position being in Corporate Quality and Validation, requires
leadership and subject matter expertise attributes. Strong
presentation skills and a proven record of accomplishment of
achievement in developing and implementing successful computer
validation policies and procedures are required. Strong Quality
Systems knowledge is preferred.