Process Engineer Lead - Global Manufacturing Technology

at  Zoetis

locations
Tullamore
time type
Full time
posted on
Posted Today
job requisition id
JR00015394
The Global Manufacturing Technology 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 processing unit operations.

Position Responsibilities

• Manage manufacturing process recipes, facility fit and equipment setups for New Product introductions and process updates.
• Accountable for delivery of technical documents, including protocols, reports and SOPs supporting the manufacturing process. Assists in evaluating process equipment and controls.
• Support new product introduction, process technology transfer, process validation and. Owning and driving significant cross-functional scopes of work associated with the technical transfer of new products.
• 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.

Organisational 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, DSP and Eng teams within the manufacturing department and with external stake holders such as QC and WHSE.
• The role will require strong interaction with Engineering department. This role involves building effective working relationships with other functional organizations, such as Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Regulatory, and others, both internally and externally to the site.

Education and Experience

• BSc, MSc in a relevant discipline (e.g., biochemistry, chemistry, process engineering) or equivalent experience.
• 5+ 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, cGMP and US / EU regulations.
• Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
• Excellent 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

• Experience in the design, modification and optimization of upstream and downstream processes steps.
• Experience in process optimization troubleshooting for manufacturing processes.
• Experience of Delta-V, Unicorn or other Manfucturing Automation systems.
• 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.
• 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.

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.

• Manage manufacturing process recipes, facility fit and equipment setups for New Product introductions and process updates.
• Accountable for delivery of technical documents, including protocols, reports and SOPs supporting the manufacturing process. Assists in evaluating process equipment and controls.
• Support new product introduction, process technology transfer, process validation and. Owning and driving significant cross-functional scopes of work associated with the technical transfer of new products.
• 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