Location:  Grange Castle            

Job Title: Equipment Validation Engineer

Reporting to: Parenterals Technical Operations Lead

Job Purpose:

The purpose of the Equipment Validation Engineer role is to provide support and subject matter expertise in improving and maintaining validation compliance within Technical Operations at Grange Castle.  The role supports all Equipment and Process Validations in the Parenterals OpU.  

This role focusses on tasks including but not limited to:

• Optimising and alignment of validation and compliance strategy across the Parenterals Technical Operations team using risk-based approaches and through collaboration across cross-functional site and network teams
• Supporting Parenterals inspection preparation activities to ensure continued inspection readiness
• SME support of validation investigations

Responsibilities:

• Providing SME support on validation strategy as required to support ongoing Parenterals Sustaining equipment and projects   

• Supporting standardizing process validation practices across Technical Ops in Parenterals

• Participating in review of validation documents (strategy and supporting documents, protocols, reports)

• SME on validation deviation resolution

• Alignment of GC governing validation procedures to enhance compliance

• Supporting the implementation of relevant Pfizer Quality Standards (PQS), Policy Memos (PM), Compliance Analysis Status (CAS) reports and Good Practice Bulletins (GPB) as required

• Participating in audit readiness activities for Tech Ops as required

• Supporting Continuous Improvement projects in Parenterals. 

• Liaise with industry and Pfizer network groups with benchmark and share best practices.  

Qualifications

• A minimum of 5 years cGMP industrial experience with good technical writing skills

• Experience in either equipment, process and cleaning validation

• Knowledge of Quality requirements and Regulatory guidelines

• Demonstrated ability to manage multiple projects

• Demonstrated ability to prioritize work, to act and work independently

• Has excellent organizational skills

• Demonstrated experience managing complex quality and technical activities

• Takes initiative and is proactive and persistent

• Demonstrated aptitude for technical learning and problem solving

Education:
Minimum qualification of a B.Sc. Degree in Bioprocess Science, Engineering, Biotechnology or equivalent with a preference for Biochemical, Chemical or Biological disciplines

Working Patterns and Duration
Day based Monday to Friday.

Work Location Assignment: On Site

All applicants must have relevant authorisation to live and work in Ireland.

We will only accept applications from colleagues via the formal route within Workday. Please do not submit paper or e-mail applications. 

In line with good development planning, colleagues should discuss their suitability and/or readiness for a vacancy with their line manager prior to application. Colleagues are required to inform their manager if they are invited to attend interview. Where a line manager is not able to support an application either for suitability, readiness or business reasons, and a colleague continues to make an application, it is possible that an offer may not be made or may be withdrawn. 

Applications not received by the closing date will only be accepted in exceptional circumstances and will require the support of your senior management team. 

Purpose  

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. 

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. 

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.