Manufacturing Engineer - Biopharmaceutical - Dublin

Newly constructed state-of-the-art biologics drug-substance manufacturing facility based in Dublin have a long term contract assignment for an experienced Manufacturing Engineer.

Working within mammallian cell culture operations we are looking for a Manufacturing Technology Engineer who has experience of downstream processes.

You will be involved in the process validation & process technical support to cell culture, purification and ultrafiltration/diafiltration unit operations for the commercial manufacture of mammalian cell processes in the Multi Product Cell Culture facility. 

Key Responsibilities:

• Investigation process deviations, root cause investigations, CAPAs, process improvements, change controls and preparation of regulatory filings
• Strong knowledge of cGMP compliance 
• Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
• Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Cruiserath Multi Product Cell Culture facility.

Experience required for this role:

• Minimum BSc or equivalent with at least 4 years’ industry experience
• Downstream / Purification manufacturing technical support in the biopharmaceutical industry including experience with process validation
• cGMP compliance & regulatory requirements
• Excellent communication & technical writing skills.

Lovely client to work for & excellent working environment! Call me for more information on this role. 




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

Please note, Quanta Consultancy Services does not sponsor Visa applications.

To view Quanta's privacy policy, please visit our website