Automation Engineer - Andelyn Biosciences, Inc

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.