Summary:
A Technical Services Specialist is required for a biopharmaceutical company in Westmeath. The successful candidate will be accountable for timely completion of all technical transfer related milestones, with particular emphasis on new product introduction, Technology Transfer, supporting start-up studies, building process data packs and performing process monitoring, study protocol generation, execution and report writing.
Responsibilities:
* Provide significant technical expertise to support all aspects of the drug product manufacturing at our client’s Fil Finish Facility.
* Process SME to support commissioning, automation and manufacturing operation teams.
* Support technology transfers of new products into the our client’s Facility.
* Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.).
* SME for introduction of single use systems and assessment of their use in terms of extractables, leachables.
* To author and review process supporting documentation, process descriptions, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
* To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.
* To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
* Technical review of change controls for impact to product quality, safety and efficacy.
* Provide on-floor technical support and troubleshooting.
* Partner with Operations to support protocol completion, execution and sample reconciliation.
* To generate documentation reports for technical studies
* Lead any key process changes using change control management system as required.
* Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
* Ensure compliance with site EHS policy, cGMP and other business regulations.
Qualifications & Experience:
* Minimum Bachelor degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
* Experience in technical services support in the drug product manufacture and/or process development and/or manufacturing support
* Experienced in relevant unit operations including formulation, sterile filtration, filling and visual inspection activities of the drug product manufacturing process.
* Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices.
* Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes.
* Prior experience in use of single use systems (single use mixers, manifolds) would be an advantage.
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