sr executive validation.

capital when required, specification of equipment and installation requirements, management of
costs to budget, and support of IQ/OQ/PQ and final documentation in accordance with acceptable
engineering practices.
• Receives assigned total project leadership responsibilities on a portion of major significant projects
and will be given total management responsibility for smaller projects.
• Manages and provides leadership for the functional group’s development, direction, and
effectiveness, adhering to organizational policies and processes and supporting overall business and
corporate objectives.
• Implements and understands FDA or regulatory requirements as necessary.
• Applies technology principles to multiple tasks. Working knowledge of cross-functional and related
technical areas.
• Advises team members pro-actively on technical ideas and promotes skill development of teamwork.
• Interacts with peers across projects to secure resources and commitments.
• Handles frequent inter-organizational and outside customer contacts. Represents the organization
in providing solutions to difficult technical issues associated with specific projects.
• Follows technical specification requirements and provides feedback on various technical processes
and procedures.
• Works cooperatively and effectively within a team environment to achieve common goals and
results, often influencing the outcome of the team(s).
• Understands FDA (CFR 820, 211, 210 and 21 CFR 11), ISO (13845 and 14971) and other regulatory
requirements and validation guidance such as GHTF 2004 and FDA Process Validation Guidance 2011,
ISPE GAMP5, PDA, ICH etc...
• Ensures compliance with Quality System and safe working practices.
• Plans, guides, and reviews projects and or work groups under one’s control to produce the desired
outcome.