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Process Scientist Global Manufacturing Technology, Tullamore Client: Location: Job Category: Other
EU work permit required: Yes
Job Reference: 4da62607a324
Job Views: 2
Posted:
Expiry Date:
Job Description: 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.
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.
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 stakeholders 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.
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.
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.
PHYSICAL POSITION REQUIREMENTS This role is primarily office-based with occasional out-of-hours support.
This role may require periods of extended hours or a modified work schedule and may require on-call availability.
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.
Visa status Colleague must be legally eligible to live and work in Ireland.
Summary of our 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.
Please note If you are NOT a passport holder of the country for the vacancy you might need a work permit.
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