Process Scientist Global Manufacturing Technology
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.
Key Responsibilities:
* Support new product introduction, process technology transfer, process validation and the preparation of CMC documentation for regulatory filings.
* 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.
* 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.
Requirements:
* 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.
* 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.
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.
* Experience in process optimization, characterization and troubleshooting for manufacturing processes.
Legal Statement:
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.
Benefits:
In addition to being part of 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.