- Provide project management oversight for FUE activities related to products and facilities, utilities, equipment (FUE).
- Developing validation plans for specific system implementation projects.
- Performing and reviewing (project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
- Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP's.
- Maintain current knowledge of industry standards and regulatory requirements for products validation techniques/approaches and systems utilized
- Lead and represent Validation in multi-departmental meetings & project teams.
- Minimum 3+ year's experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems/validation.
- Organizational and management skills to coordinate multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
