Technical Services Specialist
Our leading biopharmaceutical client offers an invaluable experience to work on their state of the art fill-finish facility.
Located in the picturesque Irish midlands, the area oozes culture and tranquillity in a town where their infamous folk music at the local a focal point of entertainment, making this one of a kind facility one of the leading places to work.
Essential Duties and Responsibilities for this Technical Services Specialist role include, but are not limited to, the following:
- Provide significant technical expertise to support all aspects of the mammalian bulk drug substance cell culture and purification manufacturing at the biologics Facility
- Process SME to support commissioning, automation and manufacturing operation teams.
- Support technology transfers of new products into the 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.
- Experience in technical services support in the manufacture of mammalian drug substance cell culture and purification and/or process development and/or manufacturing support
- Experienced in relevant unit operations including vial thaw and scale up, seed train and production bioreactors, harvest, chromatography, UF/DF, viral filtration and inactivation, final formulation and media and buffer preparations.
- 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, specifically in the manufacture of mammalian bulk drug substance operations.
- Prior experience of single use systems (bioreactors, single use mixers) would be an advantage
- Ability to present and defend technical aspects of manufacturing operations.
- Self-motivated, detail orientated enjoys the fast pace environment of startup.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
Junior Process Engineer – County Cork – Biologics – 12 month - Contract Are you looking for a step into the Pharma / Biopharma industry? Have you finished a degree or first year in
Republic of Ireland
QA CQV Specialist - Ireland - 18+ month contract A fantastic long-term contract opportunity focusing on delivering a new vial filling line. You'll be joining the Quality team with an overview of
Permit Coordinator – 12-month contract - Dublin Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.