Sr. Validations Specialist

The Sr. Validations Specialist is accountable for driving results in a fast-paced environment by supporting general pharmaceutical validation of equipment and GxP computerized systems. The ideal candidate will work on extremely complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.

Requirements

• Perform the qualification and validation of production equipment, utilities, and computer systems.
• Assist in equipment selection and specification.
• Maintain all documentation pertaining to qualification and validation.
• Develop procedures, protocols, and validation project plans.
• Serves as Validations resource for contractors and vendors.
• Execute procedures and protocols.
• Maintain the compliance of validated systems through on-going validation activities.
• Collaborate with cross-functional teams to assist in the planning, development, installation, operation, validation, and qualification of newly installed or updated equipment and/or computerized systems.
• Provide qualification guidance to IT for infrastructure and computerized system platforms.