Automation Engineer

Overview of Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space. The Andelyn Corporate Center (ACC) is dedicated to cGMP manufacturing, the Andelyn Development Center (ADC) for preclinical non-cGMP activities, and the Andelyn Plasmid Center (APC) for research and cGMP plasmid production.

Our Values are founded in our origin story.

The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.

Through this journey, we have been able to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Pioneering Solutions that Turn Hope into Reality™ through our ACCTSions.

ACCOUNTABLE in our actions.

CURIOUS to discover.

COMPASSIONATE in our thinking.

TRUSTWORTHY in our communications.

SUPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of our ACCTSions.

The Automation Engineer is a member of the Facilities and Engineering (F&E) team and will provide support to the Cell and Gene Therapy (CG&T) development and manufacturing facilities located in Dublin and Columbus, Ohio. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. This role focuses on supporting the delivery of automated solutions to support Process Development, Downstream/Upstream process, Facilities/Utilities, Warehouse, and areas including Lab, Media Preparation, Seed Culture, Small/Large Scale Bioreactors, and Harvest.

What you will do.

Develop and maintain process control automation solutions for Human Machine Interfaces (HMI), PLCs, Building Management Systems (BMS), and Supervisory Control and Data Acquisition systems (SCADA), as applicable.
Performs Automation activities, such as code configuration, document development, and test execution within several process areas
Responsible for developing and completing Deviation Reports, CAPAs, and Change Controls as part of the Quality Management System in support of the Site’s compliance readiness.
Creates standard code utilizing control strategies
Develops (generates, reviews, maintains) various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)
Builds scope of work documents for internal and external partners
Collaborates with other departments, such as Manufacturing, Maintenance, and Validation
Conducts training and presents information to the team or other stakeholders.
Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
Manage Day-to-day Operational Support including 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Mfg. Operations, Validation, Automation System Administration, Preventative and corrective maintenance, and Automation System spare parts management.
Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current CFR and Industry standards.
Working as part of a focused multi-facility team, the Automation Engineer will ensure any modification, installation, preventative maintenance, operational support, or troubleshooting activity is properly completed and documented in compliance with engineering specifications and current Good Manufacturing Practice guidelines
Work Closely with the Digital & Technology Solutions (DTS) team to ensure equipment is compatible with network protocols and security standards
This position requires the ability to lead projects, facilitate meetings, and provide consistent, and professional communication throughout all levels of the organization
Coordinate contracted service providers and ensure that work performed meets regulatory expectations
Manage contracts to ensure appropriate service levels at acceptable cost levels
Establish agreements, as requested, to assure coverage of critical systems
Position has responsibilities at multiple locations in central Ohio (Columbus and Dublin)
Ability to clearly and concisely express thoughts in written procedures, protocols, and reports
Other duties as assigned

What you bring to the team.

Bachelor’s degree in Electrical, Chemical, or Mechanical Engineering or other relevant field
Minimum of 3 years of Automation, Instrumentation & Controls, or other relevant technical experience
Understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
Experience with Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation and ability to perform troubleshooting activities, understand system Integration using OPC, and DeviceNet technologies.
Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, case development, detailed design, engineering and validation documentation, and project implementation.

Preferred Qualifications:

Direct knowledge of Automation design, experience in process control engineering and solving problems with GMP biopharmaceutical production facility equipment/systems such as Building Management Systems (BMS/EMS), harvest, bioreactors, chromatography, vial filtration, PLCs, VFDs and integrating various OEM automation software.
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, S88, ISA95 and ISPE GAMP-5

What you can expect when working at Andelyn.

The pride of contributing to the development and manufacturing of life-saving therapies.
The invaluable experience of being a part of building the foundation of a new organization.
The opportunity to work alongside experts who have over 10 years in the gene therapy field.
Competitive compensation
Eligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid
160 hours of Paid Time Off annually
11 Company Paid Holidays plus 2 floating holidays annually.
Company Paid Life Insurance
401(k) Match
Company Paid short and long-term disability.
4 weeks of Paid Parental Leave for birth and adoption
Adoption Assistance
Tuition Reimbursement and Student Loan Repayment Assistance
Company Paid LinkedIn Learning access.
Employee Assistance Programs
Flexible work options (role specific)

Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone ACCTS.

Apply for this job

First name

Last name

Email address

Location

Phone number

Resume

Attach resume

Attach another file

Attach file

What are your salary requirements?

Are you willing to relocate?

Are you authorized to work in the United States?

Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)?

Are you 18 years of age or older?

What is the highest level of education you’ve obtained?

We invite you to complete the optional self-identification questions below used for compliance with government regulations and record-keeping guidelines. Any self-identification information provided will not be considered in the selection process.

GENDER

VETERAN STATUS Learn more about veteran statuses

If you believe you belong to any of the categories of protected veterans listed below, please indicate by selecting the appropriate category(ies). The hiring employer is subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA) and requests this information in order to measure the effectiveness of the outreach and positive recruitment efforts it undertakes pursuant to VEVRAA.

DISABILITY STATUS Learn more about disability statuses

We are required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.