Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization.Located in Columbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids, and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.
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 thedevelopment and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through our ACCTS ions.
A CCOUNTABLE in our actions.
C URIOUS to discover.
C OMPASSIONATE in our thinking.
T RUSTWORTHY in our communications.
S UPPORTIVE of one another.
Employees are expected to perform the following essential functions under the framework of our ACCTS ions.
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.
- . Develop and maintain process control automation solutions 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 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.)
- Collaborate with other departments, such as Manufacturing, Maintenance, and Validation
- Conducts training and presents information to 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 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, provide consistently, and professional communication throughout all levels of the organization
- Coordinate contracted service providers and ensure that work performed meets regulatory expectations
- Establish agreements, as requested, to ensure 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.
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 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.
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