Engineering Manager Compliance & Investigations

Experienced in Facilities Engineering and Biopharmaceuticals? Take a closer look!

This Jobot Job is hosted by: Jenner Wiggins
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Salary: $130,000 – $150,000 per year

A bit about us:

We are a immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious diseases.

Why join us?

  • Competitive Base Salary!
  • Extremely Competitive Equity Package!
  • Flexible Work Schedules!
  • Accelerated Career Growth!
  • Company Matched 401(k)!

Job Details

SUMMARY:
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.

MUST HAVES:

  • Compliance & Investigations
  • GMP
  • Bio Pharma

DUTIES & RESPONSIBILITIES;

  • Responsible for Engineering oversight and managing the tracking and closure of the deviation/investigation programs and CAPA systems:
  • 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.
  • Responsible for Engineering oversight and managing the tracking of Alarm Management and trending, including providing metrics of Alarm re-occurance
  • Review and Approve CAPAs to prevent recurrence of deviations and non-conformances.
  • Responsible for tracking investigations and CAPAs for timely completion.
  • Provide status reports, including relevant engineering metrics.
  • Perform document change control activities. Write, edit, and review of controlled documents to ensure documents comply with applicable regulatory and internal requirements.
  • Periodically conducts internal auditing activities to ensure that systems are operated in accordance with established SOPs and GMPs.
  • Provide leadership, support, guidance and direction to internal engineering investigations for the team operating under cGMP regulations.
  • Identify and support continuous improvement projects in collaboration with different functional group management to achieve quality, reliability and efficiency improvement objectives.
  • Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters are addressed in an open and timely manner.

EDUCATION & EXPERIENCE:

  • Bachelor’s degree in chemistry, microbiology, engineering, or related science
  • Minimum of 5-7 years of experience in the pharmaceutical / biopharmaceutical industry and 2-3 years direct experience in management (Preferred)
  • Experience with cGMP manufacturing

Interested in hearing more? Easy Apply now by clicking the “Apply Now” button.

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