POSITION SUMMARY The Global Manufacturing Technology (GMT) group is responsible for new product introduction, technology transfers, process validation, and continued process technical support to unit operations for the commercial manufacture of multiple processes in the Zoetis Tullamore facility. The successful candidate will be a key contributor to a dynamic and highly technical team and will be required to build collaborations with Process Development, Manufacturing, Engineering, Supply Chain, Quality Assurance, Quality Control and Global Regulatory groups. The position is accountable for the timely completion of technical transfer and process validation related milestones, PPQ, process monitoring and manufacturing support. Expertise in the design, control, and operation of the manufacturing processing unit operations. POSITION RESPONSIBILITIES Support new product introduction, process technology transfer, process validation and the preparation of CMC documentation for regulatory filings. Owning and driving significant cross-functional scopes of work associated with the technical transfer of new products. Provide hands-on technical support for manufacturing process activities and support team input to investigations and resolution of process deviations, root cause analysis, CAPAs, process improvements, change controls and preparation of regulatory filings. Accountable for delivery of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process. Assists in evaluating process performance by comparing manufacturing data to historical data. Strong knowledge of cGMP 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, QA, WHSE and ENG. 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. RESOURCES MANAGED Financial Accountability N/A Supervision N/A EDUCATION AND EXPERIENCE BSc, MSc or PhD, in a relevant discipline (e.g biotechnology, biochemistry, process engineering) or equivalent experience. 3+ years experience in pharmaceutical manufacturing organization and/or bioprocess development, with experience in upstream or downstream 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, cGMP and US / EU regulations. Excellent verbal & written communications skills. Project management capability. Ability to work effectively as part of a team across all departments in Zoetis Tullamore. Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form. Knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals in commercial manufacturing. TECHNICAL SKILLS REQUIREMENTS Be proficient in ETS, SAP, Veeva Vault, strong knowledge of Excel, Word, and PowerPoint desirable. Strong strategic and analytical thinking, problem solving and rapid decision making skills. Experience in the design, modification and optimization of upstream and/or downstream processes. 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 process optimization, characterization and troubleshooting for manufacturing processes. Knowledge of Statistical Process Control, Computer Modelling, Data Analytics and related tools. PHYSICAL POSITION REQUIREMENTS This role is primarily office-based with occasional out-of-hours support. This role may (at tech transfer in-plant campaign execution support stage) require periods of extended hours or a modified work schedule and may require on-call availability. Full time Legal statement as below This job advert indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required. Additional position specific requirements/responsibilities are contained in approved training curricula. Visa status re must be eligible to work and live in Ireland as below Colleague must be legally eligible to live and work in Ireland. Summary of our Benefits In addition, to being part the world leading animal health company focused on the needs of those who raise and care for animals we offer a range of benefits such as competitive salary, bonus, 25.5 days holiday per annum plus public holidays, a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working, to name a few. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Apply button below to Login/Register.
