A Technical Services Specialist is required to support our client's Fil Finish Facility 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.
Key Responsibilities:
* Provide significant technical expertise to support all aspects of drug product manufacturing at the client's facility.
* Process SME to support commissioning, automation and manufacturing operation teams.
* SUPPORT TECHNOLOGY TRANSFERS OF NEW PRODUCTS INTO THE 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.
* Author and review process supporting documentation, process descriptions, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
* SUPPORT THE INTRODUCTION OF NEW RAW MATERIALS AND CONSUMABLES THROUGH THE GENERATION OF MATERIALS LISTS, BILLS OF MATERIAL UPDATES, MATERIAL SPECIFICATIONS.
* 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.
* Generate documentation reports for technical studies
* Lead any key process changes using change control management system as required.
* Adhere 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.
Requirements:
* 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.