Overview of Andelyn Biosciences

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 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.

 

 

What you will do.

We are seeking a highly experienced Senior Validation Engineer (CSA) to lead and support Computer Software Assurance (CSA) activities within our digital manufacturing and quality environments. This role will be responsible for ensuring that our GxP systems meet regulatory requirements and internal quality standards, with a focus on risk-based, fit-for-purpose validation approaches in alignment with FDA and global regulatory expectations. 

 

This position will work extensively in our validation lifecycle management system, Res_Q by Sware, to manage validation documentation, track periodic reviews, and ensure seamless alignment between our processes and our quality management system (QMS). The Senior Validation Engineer will collaborate closely with the Quality Assurance (QA) team, DTS team, and business system owners to ensure all system implementations, changes, and periodic reviews follow appropriate validation processes.  

 

This position will also work to define approaches to validating AI (Artificial Intelligence) programs that are being deployed as part of The Digital CDMO strategy.

 

• Develop, review, and maintain validation lifecycle documentation, including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications (FS/DS), Risk Assessments, Test Plans, Test Scripts, Traceability Matrices, Validation Summary Reports, and Periodic Review Reports. 

• Ensure all validation deliverables adhere to CSA best practices, with emphasis on risk-based testing strategies and streamlined documentation. 

• Serve as the subject matter expert for CSA, providing guidance to business system owners, project teams, and QA on compliant, risk-based validation strategies. 

• Partner with QA to ensure adherence to FDA regulations (21 CFR Part 11, Part 210/211), GAMP 5, and applicable ICH guidelines. 

• Leverage Res_Q by Sware to manage the full validation lifecycle, ensuring accurate and complete documentation. 

• Establish and maintain validation-related SOPs, Work Instructions, and templates in alignment with CSA principles. 

• Lead and perform system Periodic Reviews, ensuring validated state is maintained and documented appropriately.
• Author and execute test scripts, ensuring appropriate risk-based testing is applied, focusing on critical functionality. 
• Manage 3^rd parties and other individuals as required to augment the testing team. 
• Collaborate with the Infrastructure team to ensure proper qualification and documentation of underlying infrastructure components. 
• Provide compliance oversight of system changes, ensuring appropriate change control processes are followed within the ITSM framework. 
• Review and assess SaaS vendor validation packages for appropriateness, completeness, and alignment with internal requirements. 
• Ensure proper vendor assessments and documentation for cloud and SaaS solutions, ensuring alignment with GxP compliance expectations. 
• Collaborate with cross-functional teams (QA, IT, Business System Owners) to embed CSA processes into project lifecycles. 
• Participate in internal and external audits and inspections as a CSA subject matter expert. Plan, coordinate, and manage site-specific validation project activities including protocol development/approval, work schedules, and lifecycle documentation  
• Infrequent travel required 
• Influences hiring, development, and related personnel processes 
• Mentoring and professional development of staff 
• Other duties as assigned 

 

What you bring to the team.

• Bachelor’s Degree in Computer Science, Engineering, Life Sciences, or related field. 

• Minimum 10 years of experience in Computer Systems Validation (CSV), Computer Software Assurance (CSA), or Software Quality Assurance in a regulated (pharmaceutical/biotech preferred) environment. 

• Strong knowledge of FDA regulations, including 21 CFR Part 11, Annex 11, and GAMP 5 principles. 

• Extensive experience authoring and reviewing validation documentation. 

• Experience implementing and maintaining risk-based validation approaches. 

• Strong technical knowledge of SaaS applications, cloud platforms, and infrastructure qualification principles. 

• Familiarity with ITSM and Change Management processes (preferred in a GxP environment.) 

• Hands-on experience working in validation lifecycle management tools, with preference for experience in Res_Q by Sware. 

• Strong understanding of periodic review processes and maintaining the validated state. 

• Excellent communication and collaboration skills, with the ability to partner effectively across QA, IT, and business teams. 

• Project management experience a plus 

• Experience participating in regulatory inspections and audits as a validation SME. 

• Ability to manage multiple priorities in a fast-paced, evolving environment. 

• Strong analytical and problem-solving skills. 

• Ability to apply critical thinking and risk-based decision-making to validation challenges. 

• Detail-oriented with strong documentation and organizational skills. 

• Ability to mentor and train cross-functional teams on CSA/CSV principles. 

• Experience with systems traditionally used in pharmaceutical manufacturing settings (LIMS, MES, QMS, ERP, etc.). 

• Familiarity with vendor audit and management processes for SaaS providers. 

 

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 that 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 Paid Holidays plus 2 floating holidays annually.
• Company-paid 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.