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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.