The Global Manufacturing Technology group is responsible for new product introduction, technology transfers, equipment and process validation, and continued process technical support to unit operations for the commercial manufacture of multiple processes in the Zoetis Tullamore facility.
Position Responsibilities
* Define, execute, and report qualification, re-qualification, and validation studies in order to establish and maintain the qualified/validated status of range of facilities, utilities, and equipment in accordance with internal procedures, regulatory requirements, and industry guidance/standards.
* Provide technical expertise for investigation and compliant resolution of non-conformances encountered during requalification, revalidation, and periodic review activities (with support from senior validation team members).
* Advise systems owner and vendors on suitability and required standards/functionality of new systems during the selection process.
* Strong knowledge of c GMP compliance, site and regulatory agency requirements and provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
* Participates in continuous improvement initiatives, action plans to implement operational excellence, and lean practices along with setting and maintaining department goals and metrics.
Organizational Relationships
This role will include working with teams, both in Zoetis Tullamore and externally with Contract Manufacturing Organisations. The role will involve interaction with USP, and DSP teams within the manufacturing department and with external stake holders such as QC, WHSE and ENG. The role will require strong interaction with QA. This role involves building effective working relationships with other functional organizations, such as Process Development, Manufacturing, Quality Assurance, Quality Control, Engineering, Supply Chain, Regulatory, and others, both internally and externally to the site.
Education and Experience
BSc, MSc, or Ph D, in a relevant discipline (e.g., biochemistry, chemistry, pharmaceutical science, biology, engineering) or equivalent experience. 3+ year's experience in pharmaceutical manufacturing organization and/or bioprocess development, with experience in upstream unit operations, process scale up, facility fit and process validation. Experience with large scale manufacturing support for mammalian cell culture, upstream and downstream processing, Single Use Systems, c GMP, and US / EU regulations.
Technical Skill Requirement
Be proficient in ETS, SAP, Veeva Vault, strong knowledge of Excel, Word, and Power Point desirable. Strong strategic and analytical thinking, problem solving and rapid decision-making skills. Demonstrated capability in implementing challenging goals, objectives, and practices in a complex and ambiguous/matrix environment. Understanding of project management systems and tools. Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner. Experience in qualification of, upstream and downstream processing equipment.