Process / Equipment Engineer

Pfizer; South Dublin; Hybrid; EUR 70,000 - 95,000; Full time

Job summary

Pfizer in Ireland is seeking an Equipment/Process Engineer for the Bio-Vaccine Suites to provide process engineering support, ensure robust and reliable equipment, and resolve issues to sustain manufacturing efficiency. You will lead root cause investigations, CAPA, and participate in validation and periodic reviews with cGMP compliance, supporting audits and continuous improvement through IMEx and DOC.

Hybrid work in Ireland, 3-5 years Biopharmaceutical experience preferred; third level

Qualifications

• Third level qualification in Science or Engineering.
• 3-5 years’ experience in the Biopharmaceutical/pharmaceutical industry.
• Experience with validation/revalidation is advantageous.

Responsibilities

• Provide routine equipment technical support and troubleshooting for manufacturing issues.
• Lead root cause investigations and CAPA implementation.
• Support validation activities and periodic review programs for equipment and processes (IQ/OQ/PQ/QV).
• Drive continuous improvement and participate in Capital Project teams as SME for end-user requirements.

Skills

Root cause analysis

Troubleshooting

CAPA

Communication

Education

Science/Engineering degree

Tools

eQMS

QTS

MCS

PI

Job description

General Information

Job Title: Equipment/Process Engineer
Department: Technical Operations (Bio-Vaccine Suites)
Position Reports to: Plant Engineering Lead
Type: Permanent Secondment

Job Purpose

Provide process engineering/technical support to support the ongoing requirements of the Bio-Vaccines Suites. The process engineer is responsible for providing support to the operating unit ensuring that the equipment is robust, reliable and all issues are resolved to support the effective and efficient manufacture and disposition of product.

Job Responsibilities

• Equipment and Process Support: Provide routine equipment technical support and troubleshooting for resolution of manufacturing issues. Lead Method 1's to determine root cause and implement corrective actions. Lead investigations for equipment and process related issues, providing product/process impact assessments, appropriate root cause analysis and effective CAPA implementation. Provide equipment technical support/troubleshooting and implement process/equipment CAPA’s and improvements. Support the shift engineering teams with routine technical support and troubleshooting.

• Validation and compliance: Generate and implement documentation for cGMP re-validation and periodic review of systems, equipment and manufacturing processes including Annual Re-Validation Plans and Risk Assessments and IQ/OQ/PQ/QV Protocols and Reports to ensure equipment remains validated 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. Perform, execute and close out the annual periodic review programme for recently qualified equipment.

• Continuous Improvement: Use Integrated Manufacturing Excellence (IMEx) and the Digital Operations Centre (DOC) to drive success in the Safety, Quality, Supply, Finance and People metrics. Identify process & equipment improvements, safety initiatives and develop these into Continuous Improvement (CI) projects. Work to implement a culture of Right-First Time and Zero Defects through partnerships with Operations and Core Engineering and Core Technical Services. Represent Tech Ops Process Engineering for the Eqpt. Reliability Programme. Highlight equipment reliability concerns / Spare Parts Obsolescence concerns.

• Capital Projects: Represent Tech Ops Process Engineering on Capital Project teams where responsibilities would include SME technical input / End User requirements input.

Education & Experience

Third level Qualification in Science, Engineering or equivalent is preferred, though not essential. Exceptions may be considered where relevant skills, experience, and application exist (this may be supplemented by further education in parallel). 3-5 years’ experience in the Industry, preferably Biopharmaceutical/pharmaceutical. Experience and working knowledge of validation/revalidation systems. Excellent communication and interpersonal skills and an ability to work independently and in a fast paced, dynamic environment. Experience working with the compliance systems eQMS and QTS or similar. Working knowledge of MCS and PI. Experience of regulatory inspections. This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.

Work Location Assignment

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

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.

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!

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Engineering Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.