Responsible for the self-directed supervision of the day-to-day operations of Validation team members to support the value stream. Lead their team as a front-line leader (hands-on, on the floor, management). Assign day-to-day validation tasks, set objectives, and define professional development plans for team members. Develop and improve validation procedures, practices, and policies. Develop team to become proficient in validation activities (e.g., equipment qualification and cleaning validation).Set priorities, fulfill customer needs, define timelines, and track projects supporting the value stream. Ensure team deliverables are met within defined timelines. Oversee the development of required validation studies and protocols for facilities and equipment and lead the effort to approve protocols and associated reports. Support deviation investigations and remedial actions as required, managing the implementation of quality and safety continuous improvements. Interface with other departments to coordinate resources and complete validation activities in a timely manner. Development of Validation Project Plans to support major changes to the site for new product introduction and technology transfers. Oversee the implementation of validation activities for all manufacturing equipment within GSK's 2000L value stream to enable clinical and commercial manufacture of multiple products to be introduced rapidly and manufactured efficiently with quick changeovers. Review of new and modified systems to ensure designs comply with current validation standards and systems are able to be adequately validated. Propose strategies and priorities in planning technical transfer/process validation activities within area of expertise. Establish the cleaning validation strategy for all new products coming into the 2000L value stream including establishing the guidance for cleaning validation of a multi-product facility, scoping the worst-case conditions for the existing and expected products, defining the plan for validating those worst-case conditions, and designing the assessment for new products to compare to the existing validated state.Minimum Requirements:Must have a Bachelor's degree (or foreign equivalent) in Biochemical Engineering, Biology or related field, and 5 years of progressive validation experience along with the following:
3 years of experience in people or matrix leadership consisting of peers, subordinates, or senior personnel in multidisciplinary teams involving scientific, engineering, and operational disciplines;
3 years of experience utilizing current GMP's, NIH Guidelines and FDA or European validation practices for biopharmaceutical processes and supporting regulatory audits as SME;
2 years of experience in the validation of large-scale bulk biopharmaceutical facilities including cell culture, or microbial fermentation, or protein recovery and purification operations including hands-on experience with single-use systems used in biopharmaceutical processes. and
2 years of experience in utilizing industry and validation practices related to technology transfer and product lifecycle including executing technology transfer plans.