Job description
Closing date for applications is on 21st October 2022.
This is an ideal development opportunity to join a dynamic team who provide process science support/ new product tech transfer into the drug substance facility at Pfizer Grange Castle.
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.
Our Culture is hugely important to us at Grange Castle. It is the embodiment of how we act, lead and engage with people every day. Our vision is, together, we deliver life changing medicines to our patients. Our success is achieved through the commitment, engagement and excellence of all our colleagues.
We Are Seeking Process Scientists/Engineers Whose Role Will Be:
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Key member of the tech transfer team, working within site Technical Services supporting the transfers of new products into the drug substance facility and representing the site at key internal and external tech transfer meetings.
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Capture all aspects of the existing process and equipment to ensure that an equivalent process is transferred to Grange Castle
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Technology Transfer, including Gap Analysis, Process Transfer Risk Assessment, process description, new material introduction support etc.
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Execute requisite process trials to facilitate transfer as required
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Develop process validation protocols and lead their execution in conjunction with Operations.
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Generate process validation summary reports and associated filing submissions.
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Ensure the process automation meets the requirements of the process
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Process input to equipment specification process, including equipment sizing, specification of key components, verification documentation and process instrumentation ranges.
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Liaise with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to GC
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Lead major process investigations as requested and support the implementation of CAPAs.
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Provide technical training on process and technology areas as required by the project.
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Provide independent decision making for strategic input into the facility & equipment design, support site operational readiness (equipment, process understanding etc.).
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Deliver presentations that distill complex ideas and proactively communicate results and progress to technical teams, management, and business leadership.
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Be competent with Quality Systems, including Change Controls, Commitments and Maintenance systems.
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Support Compliance Inspections and enquiries from Regulatory Agencies.
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Provide technical oversight of routine process monitoring and follow-up on any significant adverse trends.
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Perform Continuous Processing Monitoring (CPV) on commercial processes.
Requirements
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Minimum of 2 – 5 years’ experience working in a manufacturing process; process development or tech transfer environment -
Knowledge of technical transfer
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Demonstrated aptitude for technical learning and problem solving.
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Strong background in mammalian cell culture, protein purification or validation.
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Good communication skills.
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Experience of FDA and EU licensing desirable.
Education
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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.
Skills:
- Demonstrated technical capability and aptitude for technical learning;
- Strong evidence of problem-solving/trouble-shooting skills;
- Ability to independently plan and perform work assignments, interpret and present data;
- Capability of working in a multi-disciplinary team environment;
- Strong interpersonal skills with an ability to work independently across sites and teams;
- Highly motivated, proactive and persistent;
- Effective communication (verbal, written);
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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