PE Global is currently recruiting for a Materials Technical Specialist for a leading multi-national Biotech client based in Dublin West.
This is an initial 12-month contract position.
ROLE:
- Acting as technical SME to support the selection and introduction of critical raw materials and single use components
- Providing technical leadership for material/component related issues, complaints, and investigations
- Liaising with Vendors to ensure they conduct adequate investigations and implement appropriate corrective actions when issues are identified
- To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements
- 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
- Lead any key process changes using change control system
- 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 and participate in risk assessments, audits, and incident investigations
- To serve as a subject-matter expert (SME) on NMI and process support during regulatory agency inspections
REQUIREMENTS:
- Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering
- Experience in Technical Services / Process Development / Manufacturing in a biological bulk drug substance manufacturing organization
- Technical and operational knowledge of multiple unit operations in drug substance manufacturing.
- Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
- Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings
- Ability to present and defend technical and scientific approaches in both written and verbal form
- Ability to drive for results independently and adapt to rapidly changing priorities
- Experience of Technology Transfer activities is advantageous
- Detail orientated
- Technical writing competency
Interested candidates should submit an updated CV.
Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to sean.molloy@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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