1+ months

Technical Services Specialist

Pfizer
Colton, NY 13625
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Applications will close 13 May 2020.



**Position Summary**



Situated in Co. Kildare, Pfizer Newbridge is an integral part of the global solid oral dose network; manufacturing tablets and capsules for world markets using highly complex processes. The site has been an established leader in the supply of medicines for over twenty years and is currently expanding its portfolio.



The Technical Services team is recruiting for colleagues to work with us at this exciting time for the facility.



+ We support the commercial supply and technical transfer of products using a range of technologies such as Process Analytical Technologies and Advanced Process Control.

+ We continuously improve and enhance our facility through the execution of complex

+ Projects introducing next generation manufacturing processes. These are deployed using six sigma and lean methodologies.

+ We have a pilot scale plant (the Technology and Innovation Centre) with the capability of carrying out development at 1kg to 50kg scale across all principle unit operations.

+ We own the validation of a diverse range of manufacturing and cleaning processes which supply all markets including the USA, EU and Asia.

+ We work in a fast paced environment where learning and personal development are actively encouraged.

+ We pride ourselves on our culture of high performance team-work and innovation which enables the business to deliver on its commitments.



The successful applicant will support the completion of process development and validation projects in accordance with cGMP and safety requirements. Liaise with manufacturing units, Quality, Engineering, Warehouse, and Technical services staff.

They will be a member of tight knit, high functioning team but will be given solo responsibilities commensurate with their experience.



**The role of Technical Services Specialist will include the following responsibilities:**



+ Support to the process centered teams with respect to oral solid dosage manufacturing processes and unit operation, including cleaning processes.

+ Data capture and analysis. The ability to use a knowledge of statistical methods of analysis in order to interpret process data.

+ Coordination and management of projects including process development, technical transfers, process and cleaning validation.

+ Preparation of documentation for each study to ensure a robust process capable of meeting all acceptance criteria.

+ Execution of all activities in accordance with cGMP, regulatory requirements, validation master plans, procedures and protocols.

+ The monitoring of process robustness and reporting to stakeholders.

+ The interpretation of data and trends to drive decisions and actions.

+ Completion of activities within agreed timeframes and plant schedules.

+ Promote an awareness of best practices and validation principles within Pfizer, Newbridge.

+ Keep up to date with the latest developments, trends and regulations within the industry.

+ Provide training and development for colleagues across the site.

+ Recommend and implement process improvements and changes based on development work and scientific rationale.

+ Evaluate proposed changes to validated processes /equipment/procedures and execute validation where required.



**Qualification Requirements:**



+ Educated to degree level in Science, Pharmacy, Engineering or a related discipline. Training in statistical methodology is an advantage

+ Three years relevant experience in the Oral Solid Dosage Pharmaceutical industry.



Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years Pfizer has worked to make a difference for all who rely on us. If you can bring your talents and enthusiasm to our team you will be joining some of the world's foremost experts in making tablets and capsules to deliver these goals.



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



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



Manufacturing
Posted: 2020-04-30 Expires: 2020-07-02
Sponsored by:
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Technical Services Specialist

Pfizer
Colton, NY 13625

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