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Process Technical Specialist

Manufacturing / Production
Siobhán Lane
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Job Reference: JO-2008-65345_1597843457



* Provide Technical Support for the commissioning and qualification of the drug substance manufacturing process.

* Work with site support groups to deliver qualified raw materials and consumables for the manufacturing process.

* Support the technology transfer of drug substance manufacturing process through effective collaboration with business partners and customers.

* Author, review and approve manufacturing documentation associated with transferred processes.

* Troubleshoot manufacturing issues and lead investigations through scientific problem-solving approaches.

* Partner with quality groups to support change management for the manufacturing process.

* Generate study plans, protocols and summary reports to support the manufacturing process.

* Establish and lead implementation of the continued process verification program to effectively manage product life cycles.

* Adherence to highest standards for Compliance (Quality and Safety)

* Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, regulatory inspections and incident investigations.

* Actively participate in a culture of Continuous Improvement and process optimisation by deploying Six Sigma tools.

* Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.


* BSc Biochemistry, Microbiology, Chemistry, Engineering or a related field

* 2 years experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience

* Experience in at least two of the following areas protein chemistry, process engineering, cell culture, purification technologies, process operations, statistics, technology transfer, microbiological control of bio-manufacturing processes, cleaning validation, process validation, regulatory inspections.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Siobhán Lane
Siobhán Lane
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