Validation Specialist - Global Manufacturing Technology

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. 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 equipment qualification,  technical transfer and process validation related milestones, PPQ, process monitoring and manufacturing support. Expertise in the equipment, utility , and facility validation.

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 status 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 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, 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 & Experience

• BSc, MSc, or PhD, 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, 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.
• Project management capability.
• Ability to work effectively as part of a team across all departments in Zoetis Tullamore.
• Knowledge of quality systems, Quality by Design, validation principles for equipment, utility and facility.​

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Technical Skill Requirement

• 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.
• Experience in qualification of , upstream and downstream processing equipment.

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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.

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 requi