Technical Services Specialist

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.