Job Description
External Manufacturing Technical Operations Consultant required for a multinational pharmaceutical client.
This role involves supporting the commercial production of sterile drug products at External Partner sites in Europe.
The ideal candidate will have a strong background in GMP functional areas and experience with technology transfer, process improvement, and statistical analysis.
Key responsibilities include:
- Working with External Partners to achieve business goals and establishing a common culture.
- Providing technical support for commercial manufacturing processes, including authorship of change control and management of process improvement projects.
- Supporting technical transfer activities, including authorship and/or review of GMP documentation and regulatory filings.
- Providing on-site coverage at External Partner sites in support of Commercial and/or Technology Transfer Person-In-Plant Activities.
Requirements:
- Bachelor's Degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology.
- Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area.
- Experience with drug product technology transfer in Fill Finish and/or Pre-filled Syringe.
- Travel will be a requirement of this position at approximately 25-50% in Europe.
Career Wise Recruitment is a specialist recruitment agency established in 1999, providing career opportunities in the life sciences, ICT, engineering, food, and agri sectors.
We operate out of multiple locations in Ireland and have offices in various locations.
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Skills: External Manufacturing Technical Operations Consultant, GMP functional areas, technology transfer, process improvement, statistical analysis.