Senior Manager responsible for Engineering and technical direction at PCI Pharma Services. Leading teams to support pharmaceutical product manufacturing with compliance to cGMPs.
Responsibilities
Accountability for all aspects of Engineering, Instrumentation & Controls, and Metrology
Provide quality and technical direction and leadership
Manage people, processes, and site CAPEX projects
Ensure adherence to cGMPs and PCI’s established SOPs
Facilitate a strong culture of Lean and Continuous Improvement
Coaching, mentoring and development of direct reports
Support a variety of regulatory and client audits
Requirements
Bachelor’s degree in engineering discipline preferred
Master’s degree in engineering or business administration preferred
Operational background in cGMP environment, preferably in aseptic manufacturing/engineering
8+ years of experience in the field of technical engineering support to biopharma/pharm and/or medical device facilities
8-10 years of experience in management of professional and technical staff
Experience in working with regulators during inspections/audits is highly desired
Excellent organizational skills
Ability to prioritize multiple ongoing projects and activities
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