A Technical Operations Specialist is required by CareerWise Recruitment for our Irish based pharmaceutical client. Our Large Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open position to support sterile drug product manufacture within our External Manufacturing Network in Europe. This is a remote position based in Ireland with 20% travel to Europe.
THE ROLE:
- Manages technical issues relating to the global external manufacturing of commercial Drug Product.
- Takes accountability and ownership for technical deliverables on their assigned projects.
- Provide technical leadership within Technical Operations group for the management of sterile drug product.
- Support technical transfers of new sterile drug product to our contract manufacturing sites.
- Lead to resolve technical issues relating to a product line or major technical projects within Technical Operation.
- Provide direct leadership for day-to-day technical activities for commercial drug product manufacturing –i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation etc.
- Independently act as the primary interface on technical issues between Technical Operations and third-party drug product manufacturers.
- Provide technical leadership on Change Controls, investigations, and CAPAs and support of Health Authority Inspections.
- Organize and lead ad hoc cross functional teams to manage investigations and implementation of CAPA and change controls.
- Coordinates and manages risk assessments and develops solutions to complex issues that require a high degree of ingenuity, creativity and innovation. Requires understanding and application of principles, concepts, practices and standards that govern the manufacturing of sterile products.
- This role includes approximately 25% travel.
REQUIREMENTS:
- Education and Minimum Requirements
- Bachelor’s degree in engineering, biological/chemistry sciences or related discipline
- A minimum of 5 relevant work experience in manufacturing, in the areas of process start up, routine manufacturing and/or technical transfer.
- A minimum of 3 or more years of experience in sterile/ aseptic Drug Product processing including formulation and filling and technical transfers
- Experience in Relationship Management
Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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