Manager, Automation Engineering

Genezen•Lexington, KY

20h•Onsite

About The Position

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The Automation Engineering Manager is responsible for leading the automation engineering team at Genezen’s Lexington facility. The incumbent will serve as the key decision maker implementing program enhancements and overseeing equipment onboarding and process improvements. The candidate will establish goals and priorities for their team and act as the primary liaison between both internal customers and external service providers.

Requirements

B.S. in Engineering, Computer Science, or related field
8+ years of relevant working experience including 3 years of management experience in a comparable position (similar type of work, similar group dynamics)
Ability to troubleshoot PLC and SCADA systems.
Familiarity with cGMP operations, GAMP5 requirements and CFR 21 Part 11 regulations.
Experience with pharmaceutical / biopharmaceutical equipment commissioning, validation, and performance monitoring.
Must be able to communicate effectively in writing and orally across the organization and at multiple levels.
Positive attitude, service oriented, and willingness / ability to perform maintenance on all equipment, systems, and facilities.
Must be capable of multi-tasking and performing assignments that have loosely defined objectives which require investigation of numerous variables.

Nice To Haves

Experience with Allen-Bradley and Johnson Controls is desirable.

Responsibilities

Ensure all process and building control systems remain operable and reliably maintained in their qualified state.
Oversee all new system installations/ integrations and existing system modifications/ upgrades as well as authoring and reviewing any associated support documentation.
Serve as the primary administrator for all CFR 21 Part 11 controls related to Manufacturing and Utility systems including access control, data integrity and audit trail reviews.
Provides budgetary and schedule estimates for all automation related projects.
Manage and mentor automation engineering staff providing clear direction, expectations and goal setting.
Provides technical support and analysis for the resolution of deviations, investigations, and automation issues.
Develops test scripts, automation procedures and specifications as necessary.
Represent department at client and cross functional meetings serving as the key stakeholder for all automation related topics.
Perform goal setting and period performance reviews of direct reports in alignment with corporate objectives.
Adaptability required as work schedule may change based on business needs
Criminal background check required
Other duties as assigned