Lab Technical Services Specialist

Summary:
Our client is a bio pharmaceutical company based in Cork , looking for a Technical Specialist to provide support to the Lab Ops Technical projects group.

Responsibilities:

• Provide Technical Support for the commissioning and qualification of laboratory equipment including equipment IOQ and PQ.
• Work with site support groups to deliver qualified raw materials and consumables for the manufacturing process.
• Author, review and approve manufacturing documentation associated with transferred processes.
• Troubleshoot technical issues and lead investigations through scientific problem-solving approaches.
• Partner with quality groups to support change management to implement process improvements.
• Generate study plans, protocols and summary reports.
• Establish and lead implementation 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.

Qualifications & Experience:

• B.Sc. Degree in Biochemistry, Microbiology, Chemistry, Engineering or a related field.
• 3+ 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.
• Evidence of Continuous Professional Development and cross skilling.