Job description
Process Scientist, Tech Services Vaccine Conjugation
Job Purpose
Provide process science and engineering, manufacturing technology and validation support to the ongoing requirements of the Drug Substance Vaccines PPU. Responsibility is to ensure that the appropriate equipment and process conditions are used to affect the desired process, ensure that the process is running as intended, that it is appropriately validated and run so as to maintain that validated state.
This role focuses on process monitoring and trouble-shooting, including leading process robustness investigations, implementation of cost reduction/cycle time improvement projects, facility and equipment design, validation studies and support of the CI Tier 1 and Tier 2 projects. There is also a strong requirement to support submissions and queries from Regulatory Agencies.
The job-holder works with the Technical Services Teams to deliver integrated technical services to meet the site business objectives. The role requires the flexibility to move from one project quickly or to work on multiple smaller projects at the same time.
Job Responsibilities
- Carry out process monitoring of commercial processes and work to improve process capability where weaknesses are identified.
- Support and respond to queries from Regulatory Agencies.
- Lead major process robustness investigations as requested and support the implementation of CAPAs.
- Write product/process impact assessments in support of investigation closures, as requested.
- Work to implement a culture of Right-First Time through partnerships with Operations and other functions on site and provide leadership in the use of OE principles to optimise our technical and business processes.
- Help maintain the process model/mass balance for the processes
- Ensure the process automation meets the requirements of the process
- Assist in the raising and execution of change controls for Technical Services
- Provide process expertise for trouble-shooting and resolution of manufacturing process and technology issues.
- Own the Process Flow Diagrams (PFDs).
- Provide technical training on process and technology areas as required.
- Support Compliance Inspections.
- Develop and maintain productive links with process equipment & technology supplier and vendors.
- Prepare and execute process and cleaning validation protocols. Write up the associated reports
Experience
- Ideally 3-4 Years cGMP industrial experience, ideally covering Operations, Engineering, QC, Projects or Validation within bioprocess manufacturing
- Strong knowledge of Prevnar drug substance manufacture preferred
- Proven track record of using Six Sigma tools to drive improvements
- Experience of cleaning validation execution preferred
- Experience of FDA/EU licensing and presenting to inspectors
- Demonstrated aptitude for technical learning and problem solving
- Continuous improvement mindset to drive positive change
Education
Minimum qualification of a B. Sc. Degree in Engineering, Bioprocess Science, Chemistry, Biotechnology or equivalent with particular emphasis in Biochemical, Chemical or Mechanical discipline.
Work Location Assignment: Flexible
Additional Information
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In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
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Please note there is no relocation support available for this position
How to apply
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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.
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