Process Equipment Engineer Lead

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

What You Will Achieve

Working with Pfizer’s dynamic engineering team, you will play a critical part in provides technical or business support to engineers on a variety of technical tasks. Your documentation skills will help to prepare engineering documentation, reports and drawings. You will be conducting preliminary analysis of trajectory adequacy data, model dimensional consistency and quantitative judgements concerning technical data. You will also support the team by conducting tests and recording data to assist engineering evaluations.

As Process Engineer lead you will be part of the Technical Engineering leader ship supporting 12k Drug Substance 2k SFF and S7 Operating areas, your knowledge and skills will contribute towards the goals and objectives of the team. Your ability to lead team members to meet targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

1.General Information:

Job Title: Process Engineering Lead

Department:12k Drug Substance 2k SFF and S7 Operating Unit (OpU)

Position Reports to:Technical Engineering Lead

Role Summary

You are responsible for leading the technical engineering process engineer team within the Drug Substance 12k, 2k SFF and S7 Operating Unit (OpU)). You are accountable for ensuring procedures and equipment are safe, compliant, reliable, robust and developing a high performing team targeted at supporting the manufacture and disposition of products in the 12k Drug Substance 2k SFF and S7 Manufacturing suites.

Reporting Structure:

This role reports into the 12k Drug Substance 2k SFF and S7 Technical Engineering Lead

How You Will Achieve It

The Process Engineer lead will have to following responsibilities:

· Manage Process Engineering resources and activities in order to maintain high-performance within the technical Engineering team and the 2k, S7 and 12k OPU’s.

· Budget management - forecast and control of Repair & Maintenance and Spares spend, set up and manage SLA ‘s and own the obsolescence program.

Be Point of Contact for the 12K Drug Substance Op U for all Digital Projects & support the Site ITRM.

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Grow the process engineering team in readiness for the introduction of new products into the 12k Drug Substance Proteins and & 2k & Suite 7 areas.

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Develop a team of Subject Matter Expert's delivering support within technical engineering in both the 12k, 2k and suite 7 manufacturing processes.

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Provide support for the Engineering Planning team to ensure that the Maintenance Program is being executed as per Site Procedures.

Lead and develop the process engineering approach and strategy during regulatory inspections. Ensure the engineering team and areas are always in an audit ready state.

Provide technical and compliance review of testing protocols, reports and applicable manufacturing SOPs.

Lead major Equipment investigations and implement equipment CAPA and performance improvements.

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Support the Building revalidation program, ensuring that the revalidation team have the necessary support to successfully deliver the annual revalidation plan, Plan 136.

Identify equipment improvement and develop these into project scopes for Core Engineering/ Technical Services, this may also include progressing to funding approvals.

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Support Compliance Inspections and enquiries from Regulatory Agencies.

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Provide technical expertise during audits and also to present/ defend engineering systems, applicable change controls, investigations and equipment requalification packages to the regulatory agencies if required.

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Work to implement a culture of Right-First Time through partnerships with Operations and Core Engineering and Core Technical Services

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Future Talent development and succession planning.

Education & Experience

Degree level or equivalent in science or engineering discipline. Higher scientific or engineering qualification desired.

Minimum of 5 years’ experience in biopharmaceutical / pharmaceutical industry.

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Significant experience providing technical leadership within the 12k and 2k suites is desired.

Experience working with the compliance systems eQMS and QTS is essential.

· Excellent communication skills to liaise with senior stakeholders across site and above site.

Previous regulatory audit experience essential.

Experience Desirable

Experience of FDA and EU licensing inspections.

Experience or aptitude in leading and managing project work/teams.

Experience of equipment commissioning, qualification and requalification.

Certification to six sigma green belt would be an advantage.

Work Location Assignment:Hybrid

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

Work Location Assignment: Hybrid

Additional Information

In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.

Please note there is no relocation support available for this position

How to apply

Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!

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.

Disability Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

Engineering

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