Engineering Manager Compliance & Investigations

(strong(Experienced in Facilities Engineering and Biopharmaceuticals?

Take a closer look!(/strong((br /((br /(This Jobot Job is hosted by: Jenner Wiggins(br /(Are you a fit?

Easy Apply now by clicking the “Apply” button and sending us your resume.(br /(Salary: $130,000
– $150,000 per year(br /((br /((strong(A bit about us:(/strong((br /((br /(We are a immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious diseases.(br /((br /((strong(Why join us?(/strong((br /((ul((li( Competitive Base Salary!(/li((li( Extremely Competitive Equity Package!(/li((li( Flexible Work Schedules!(/li((li( Accelerated Career Growth!(/li((li( Company Matched 401(k)!(/li((/ul((br /((br /((strong(Job Details(/strong((br /((br /(SUMMARY:(br /(As our Engineering Manager
– Investigations & Compliance you will be responsible for performing a variety of Engineering activities in support of internal GMP activities for cell therapy products.

You will provide leadership, support, and expertise for maintaining and enhancing, in a phase-appropriate manner, the compliance and investigation aspects of our Engineering projects.

(br /( (br /((br /(MUST HAVES:(br /((ul((li(Compliance & Investigations (/li((li(GMP(/li((li(Bio Pharma(/li((/ul((br /(DUTIES & RESPONSIBILITIES;(br /((ul((li(Responsible for Engineering oversight and managing the tracking and closure of the deviation/investigation programs and CAPA systems:(/li((li(Review and approve Engineering/Validation, and other investigations in support of batch release and GMP compliance.

Provide Engineering direction for investigations and CAPAs.

As necessary, independently conduct investigations.(/li((li(Responsible for Engineering oversight and managing the tracking of Alarm Management and trending, including providing metrics of Alarm re-occurance(/li((li(Review and Approve CAPAs to prevent recurrence of deviations and non-conformances.(/li((li(Responsible for tracking investigations and CAPAs for timely completion.

(/li((li(Provide status reports, including relevant engineering metrics.

(/li((li(Perform document change control activities.

Write, edit, and review of controlled documents to ensure documents comply with applicable regulatory and internal requirements.(/li((li(Periodically conducts internal auditing activities to ensure that systems are operated in accordance with established SOPs and GMPs.(/li((li(Provide leadership, support, guidance and direction to internal engineering investigations for the team operating under cGMP regulations.(/li((li(Identify and support continuous improvement projects in collaboration with different functional group management to achieve quality, reliability and efficiency improvement objectives.(/li((li(Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters are addressed in an open and timely manner.(/li((/ul((br /(EDUCATION & EXPERIENCE:(br /((ul((li(Bachelor’s degree in chemistry, microbiology, engineering, or related science(/li((li(Minimum of 5-7 years of experience in the pharmaceutical / biopharmaceutical industry and 2-3 years direct experience in management (Preferred)(/li((li(Experience with cGMP manufacturing(/li((/ul((br /((br /(Interested in hearing more?

Easy Apply now by clicking the “Apply” button.

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