Role at a glance
- Job function
-
Manufacturing & Skilled Trades Equipment Engineering & Maintenance
- Salary
- Not Disclosed
- Location
- Ireland, Dublin, Grange Castle
- Work arrangement
- Hybrid
- Employment
- Full-time
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Role Summary
The Process / Equipment Engineer provides process engineering and technical support to the Bio-Vaccine Suites, helping ensure equipment is reliable and manufacturing issues are resolved. The role also supports validation, compliance, continuous improvement and capital projects.
What You'll Do
- Provide routine equipment technical support and troubleshoot manufacturing issues.
- Lead investigations into equipment and process issues, assess product/process impact, determine root causes and implement corrective...
- Develop and implement revalidation and periodic-review documentation, and carry out the periodic review programme for qualified equipment.
- Provide technical expertise during audits and support the presentation of engineering systems, change controls, investigations and...
- Identify process, equipment and safety improvements; contribute to equipment reliability and spare-parts obsolescence concerns.
- Represent Tech Ops Process Engineering on capital project teams, providing technical and end-user requirements input.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
3–5 years’ industry experience; experience and working knowledge of validation/revalidation systems; excellent communication and interpersonal skills; ability to work independently in a fast-paced, dynamic environment; experience with eQMS and QTS or similar; working knowledge of MCS and PI; experience of regulatory inspections.
Required
- 3–5 years’ experience in the industry.
- Experience and working knowledge of validation/revalidation systems.
- Excellent communication and interpersonal skills.
- Ability to work independently in a fast-paced, dynamic environment.
- Experience working with eQMS and QTS or similar.
- Working knowledge of MCS and PI.
- Experience of regulatory inspections.
Preferred
- Third-level qualification in Science, Engineering or equivalent; preferred but not essential.
- Biopharmaceutical or pharmaceutical industry experience preferred.
Original job description
Content provided by the employer
Original job description
Content provided by the employer
1. General Information:
Job Title: Equipment/Process Engineer
Department: Technical Operations (Bio-Vaccine Suites)
Position Reports to: Plant Engineering Lead
Type: Permanent Secondment
2. 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.
3. 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.
4. 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
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!
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Engineering
About the company
Pfizer
Large Enterprise
Pfizer is a global biopharmaceutical company dedicated to the discovery, development, and manufacturing of innovative healthcare solutions. With a strong focus on improving lives through medications and vaccines, Pfizer has played a significant role in addressing various health challenges, including infectious diseases, chronic illnesses, and rare conditions. The company emphasizes research-driven approaches and collaborative efforts in its mission to enhance global health and empower patients through cutting-edge science and technology. Through its commitment to high standards of safety and efficacy, Pfizer continues to shape the future of medicine.