Automation Engineering Manager - Biotech GMP Solutions
Genezen
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Benefits offered by this job
Job summary
Genezen is seeking an Automation Engineering Manager to lead the automation engineering team at its Lexington facility. You will implement program enhancements, oversee equipment onboarding and process improvements, and set goals for the team while coordinating with internal customers and external providers.
You will manage CFR 21 Part 11 controls, develop test scripts, and provide budget estimates for automation projects, while mentoring staff and ensuring compliance with cGMP and data
Qualifications
- 8+ years of relevant experience including 3 years in management
- Experience with pharmaceutical/biopharmaceutical equipment commissioning, validation, and monitoring
- Strong written and oral communication across the organization
Responsibilities
- Ensure all process and building control systems remain operable and maintained in qualified state
- Oversee new system installations/integrations and existing modifications/upgrades
- Administer CFR 21 Part 11 controls for Manufacturing and Utility systems
- Provide budgetary and schedule estimates for automation projects
- Mentor automation staff and set clear expectations
- Support deviations, investigations, and automation issue resolutions
- Develop test scripts and automation procedures
- Represent department in client and cross-functional meetings
Skills
Education
Job description
Genezen is seeking an Automation Engineering Manager to lead the automation engineering team at its Lexington facility. You will implement program enhancements, oversee equipment onboarding and process improvements, and set goals for the team while coordinating with internal customers and external providers.
You will manage CFR 21 Part 11 controls, develop test scripts, and provide budget estimates for automation projects, while mentoring staff and ensuring compliance with cGMP and data
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