Process Scientist – Technical Services
Cpl, in partnership with our client Pfizer, are seeking a Process Scientist – Technical Services to join their team for an 11-month fixed-term contract at their state-of-the-art plant in Dublin, Grange Castle. This is a hybrid role.
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Background:
Technical Services works to anticipate and deliver on the process technology needs of the business, including technical transfers, process and cleaning validation, process optimization, and major investigation support. This is an ideal development opportunity to join a dynamic team who provide process science support and new product tech transfer into the following areas at Pfizer Grange Castle:
* Drug Substance Proteins
* Drug Substance Vaccines
* Parenterals
* Bioprocessing
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The Role:
The jobholder will work within the Technical Services teams and require the flexibility to move from one project quickly or to work on multiple smaller projects at the same time.
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Responsibilities:
1. Key member of the tech transfer team, working within site Technical Services supporting the transfers of new products and representing the site at key internal and external tech transfer meetings.
2. Capture all aspects of the existing process and equipment to ensure that an equivalent process is transferred to Grange Castle.
3. Technology Transfer, including Gap Analysis, Process Transfer Risk Assessment, process description, new material introduction support, etc.
4. Execute requisite process trials to facilitate transfer as required.
5. Develop process validation protocols and lead their execution in conjunction with Operations.
6. Generate process validation summary reports and associated filing submissions.
7. Ensure the process automation meets the requirements of the process.
8. Process input to equipment specification process, including equipment sizing, specification of key components, verification documentation, and process instrumentation ranges.
9. Liaise with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to GC.
10. Lead major process investigations as requested and support the implementation of CAPAs.
11. Provide technical training on process and technology areas as required by the project.
12. Provide independent decision making for strategic input into the facility & equipment design, support site operational readiness (equipment, process understanding, etc.).
13. Deliver presentations that distill complex ideas and proactively communicate results and progress to technical teams, management, and business leadership.
14. Be competent with Quality Systems, including Change Controls, Commitments, and Maintenance systems.
15. Support Compliance Inspections and enquiries from Regulatory Agencies.
16. Provide technical oversight of routine process monitoring and follow-up on any significant adverse trends.
17. Perform Continuous Processing Monitoring (CPV) on commercial processes.
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Requirements:
* Minimum of 2–5 years' experience working in a manufacturing process, process development, or tech transfer environment.
* Knowledge of technical transfer.
* Demonstrated aptitude for technical learning and problem solving.
* Strong background in mammalian cell culture, protein purification, or validation.
* Good communication skills.
* Experience of FDA and EU licensing desirable.
* Knowledge of single-use systems and new material introduction.
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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).