11 days old

Process Scientist

Pfizer
Grangeville, ID 83530
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Applications will close 22 June 2021.



**Job Purpose:**



Pfizer Ireland Pharmaceuticals Grange Castle manufacturing plant is situated on a 90-acre site in South Dublin. The site manufactures Biopharmaceuticals and Vaccines - with multiple manufacturing technologies, including large-scale mammalian cell culture, protein purification, vaccines conjugation, and aseptic syringe filling.



The Small Scale Flex (SSF) facility is a 2000 L scale disposable cell culture facility. We are seeking a Process Scientist within the SSF facility who will:



+ Be a key member of the team, working within the site Technical Services team to provide process technical support to the SSF facility and enable future cell culture process tech transfers and multi-product operations in the facility.

+ Support process validation of the processes running in the SSF Facility.

+ Support all associated filing submissions as well as working to ensure inspection readiness of the new processes and their validation.



**Job Responsibilities:**



+ Support the on-time delivery of the Technical Services deliverables to support the SSF plan of record and new process introductions. This can include leading major investigations, writing filing responses, implementing changes to improve processing and productivity.

+ Lead process tech transfer into SSF in line with company guidance.

+ Process Definition (Description), including Bills of Materials, Raw Materials and Consumables

+ Process Mass Balance & Flow Schematics

+ Technology Transfer, including Gap Analysis and Process Transfer Risk Assessment

+ Oversee scale up & development of processes, as required, working with Manufacturing Science & Development (MSAT) and Engineering colleagues

+ PFD/(key process) P&ID approval

+ Process input to equipment specification process, including equipment sizing, specification of key components (eg. pumps, columns), verification documentation and process instrumentation ranges

+ Oversee completion of Engineering/Demo batches

+ Execute requisite process trials to facilitate transfer (bioreactor kLa studies, media/buffer make-up & hold, cleaning cycle development, column packing, preservative flush-out, media simulations, etc)

+ Process validation execution and completion of summary reports

+ Drafting of filing submissions

+ Inspection readiness activities including preparation of playbooks.

+ Act as liaison with MSAT to support the introduction of process improvements and flexible, multi-product manufacturing strategies.

+ Support implementation of IMEX standard work practices to optimise the performance of the SSF Technical Services team.



**Experience:**



+ Minimum of 2 - 5 years' experience working in a manufacturing process; process development or tech transfer environment

+ Familiarity with the operation of cell culture (upstream or downstream) technology

+ Knowledge of technology transfer

+ Demonstrated aptitude for technical learning.

+ Strong evidence of problem-solving skills

+ Good communication skills



**Education**



+ A minimum of a B.Sc., B.E. or M.Sc./M.Eng. Degree in Biosciences, Chemical Engineering or equivalent; equivalent defined as a Biotechnology or Industrial Chemistry Degree with a large element of biotechnology in the curricular



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



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



\#LI-PFE



**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.



Engineering
Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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Process Scientist

Pfizer
Grangeville, ID 83530

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