Senior Process Engineer
Headcount Solutions is seeking a Senior Process Engineer for our client’s biotech facility in Cork. This person will work with the Vaccines Operations Team and provide support to the manufacturing team.
· Provide Technical Support for the commissioning and qualification of the drug substance manufacturing process including equipment IOQ and PQ.
· 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.
· Lead and participate in process validation studies including but not limited to, cleaning studies, mixing studies and process characterisation studies.
· Establish and lead implementation the continued process verification program to effectively manage product life cycles.
· 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.
· 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 Degree in Biochemistry, Microbiology, Chemistry, Engineering or a related field.
· 6+ years’ experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience.
· Experience in at least 2 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.