​Mantell Associates has been exclusively retained on the search for an Associate Director of Engineering with a global CDMO. Their new site has just had a $100 million investment and they are seeking an Associate Director of Engineering to join the business in what is a pivotal hire for the business.

Requirements:

• 10 + Years’ Experience, Bachelor of Science degree in an Engineering discipline. Chemical Engineering preferred.

• Experience with adherent or suspension mammalian cell culture, centrifugation, clarification, TFF (tangential flow filtration), chromatography, and sterile filtration.

• 5 + Years management experience in related Health Care industry.

• Experience in the design and operation of Biopharmaceutical facilities, both manufacturing and support systems.

Responsibilities:

• Leads effective execution of Quality Systems including documentation, justification, and impact assessments

• Strategically leads production equipment CAPEX and sustainment of GMP equipment - URS generation, equipment selection, management, capital expense process, FAT/SAT execution, pFMEA and risk assessment documentation, commissioning, and SOP development

• Manages production equipment and Automation repairs, maintenance, replacement, transfer, and coordination

• Strategically identifies solutions to production challenges and develops projects to increase efficiencies.

• Manages Equipment, automation systems and resources internally/externally as needed for projects

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For more information on this opportunity, contact Jack Dean on +44 (0)20 3778 0990 or jack.dean@mantellassociates.com.