REQUIREMENTS:

• Third level degree in science, engineering, or other relevant technical subject area
• 2+ years’ experience in biologics manufacturing in GMP environment e.g. in operations, technical operations, process validation
• Technical/Business Knowledge -Job Skills/Experience Required
• Minimum of 1 years in a similar type of role.
• Minimum of 2 years within Pharmaceutical or Bio Industries.
• Strong technical and operational knowledge of unit operation within a fill finish facility

Work closely with global science and quality teams, on the process development of suitable future products.

• Perform gap analysis, facility fit studies, process safety and risk analysis for New Product Introductions.
• Develop NPI related documents e.g., Transfer Plans/ Protocols/ Procedures/ Manufacturing Batch Records.
• Assist with the development of manufacturing process for new products.
• Prepare and update specifications related to NPI materials and consumables.
• Lead and / or assist risk assessments (e.g., PFMEA, EHS).
• Provide operational technical support for process related issue resolution.
• Monitor and analyze process data during the manufacturing.
• Assist and /or lead product and process related investigation and change plans.
• Support, supervise, and train operations personnel for NPI processes.
• Adhere to and support all EHS&E standards, procedures, and policies.
• Other duties as assigned.