The role:PE Global is currently recruiting for a Technical Services Specialist on behalf of a leading pharmaceutical company based in Athlone. This is an initial 12 month contract role.Description:
The Technical Services Specialist has responsibility for providing technical support to the drug product manufacture at the Athlone manufacturing facility.
The Technical Services Specialist is 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.
The position requires effective cross-functional working relationships with Manufacturing, Engineering, Facilities, Logistics, Quality Assurance and Quality Control groups which support day-to-day operations; interacting with Process Development and Analytical sciences for introduction of new products; and providing support for Regulatory submissions to ensure successful facility start up and process qualification.
Responsibilities:
Provide significant technical expertise to support all aspects of the drug product manufacturing at the Athlone Fil Finish Facility
Process SME to support commissioning, automation and manufacturing operation teams.
Support technology transfers of new products into the Athlone 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.
Education and Experience:
Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
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
Ability to present and defend the technical aspects of manufacturing operations.
Self-motivated, detail orientated, enjoys an interactive and works well within a team.
Interested candidates should submit an updated CV.Please click the link below to apply, alternatively send an up to date CV to***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
Expected salary
Location
Athlone, Co Westmeath
Job date
Wed, 12 Feb 2025 00:45:50 GMT
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