Downstream Manufacturing engineer

An exciting new opportunity with a global biotech company has arisen. They need an downstream manufacturing technology scientist / engineer for an initial 12 month contract working on the new product introduction and technical transfer of large scale manufacturing products into their state of the art facility in Dublin. 

Starting ASAP they need someone to support process technology transfer, process validation and the preparation of CMC documentation for regulatory filings. The Manufacturing Technology group provide process technical support to chromatographic, filtration, ultrafiltration/Diafiltration and other downstream unit operations.

Role and responsibilities;

• Investigation and resolution of process deviations, root cause investigations, CAPAs, process
• Assists in evaluating process performance by comparing manufacturing data to historical data from other sites.
• Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
• Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.

This job might be for you if:

• Minimum BSc or equivalent with at least 5 years’ experience in downstream manufacturing technical support in the biopharmaceutical industry including experience with process validation.
• You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
• Proven project management skills, including leading cross functional teams and balancing project assignments.

If you want to become an integral part of a dynamic team working with new products then please apply today!



The candidate must have the rights to work in the location stated in the job advert.

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