Engineering and Facilities Operations M

4 weeks ago


California, United States Mantell Associates Full time

Mantell Associates has formed a partnership with an innovative CDMO who is seeking a Director of Engineering.

Director of Engineering - Requirements:
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

Director of Engineering - Requirements:
Bachelor of Science degree in an Engineering discipline
Proven management experience in the related Pharmaceutical / Life Science industry
Experience in the design and operation of Biopharmaceutical facilities, both manufacturing and support systems
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm.



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