Manager, Automation Engineering

Genezen; Lexington (VA); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Paid vacation

Paid sick time

Holiday pay

401(k) match

Share Appreciation Rights

Health plans

Dental & vision care

Life insurance

Disability insurance

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

PLC troubleshooting

SCADA systems

Allen-Bradley

Johnson Controls

cGMP operations

CFR 21 Part 11

Data integrity

Written and verbal communication

Education

B.S. in Engineering/Computer Science or related field

Job description

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

Manypeople 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.

JOB 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.

ADDITIONAL RESPONSIBILITIES:

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

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EDUCATION/CERTIFCATIONS/LICENSES

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B.S. in Engineering, Computer Science, or related field

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Essential

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ON-THE-JOB EXPERIENCE

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Years of Experience: 8+ years of relevant working experience including 3 years of management experience in a comparable position (similar type of work, similar group dynamics) | Essential

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SKILLS/ABILITIES

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Ability to troubleshoot PLC and SCADA systems. Experience with Allen-Bradley and Johnson Controls is desirable.

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Familiarity with cGMP operations, GAMP5 requirements and CFR 21 Part 11 regulations.

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Experience with pharmaceutical / biopharmaceutical equipment commissioning, validation, and performance monitoring.

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Must be able to communicate effectively in writing and orally across the organization and at multiple levels.

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Positive attitude, service oriented, and willingness / ability to perform maintenance on all equipment, systems, and facilities.

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Must be capable of multi-tasking and performing assignments that have loosely defined objectives which require investigation of numerous variables.

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COMPENSATION:

The compensation range for this position is$130,00-$160,000.

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN’S CURES VALUE-BASED COMPETENCIES

C ommitted to Science
We are committed toscientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

U rgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners’ programs.

R esilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

E xecute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

S olutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN’S BENEFITS

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

ADDITIONAL DETAILS

• Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum–to name just a few reasons this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.