Senior Specialist, CSA Quality

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.

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.

This role is not limited to work also with related equipment associated with the computer systems and there Qualification or validation approach.

The successful candidate has excellent communication (written and verbal) skills, can thrive in a fast-paced environment, is quality-minded, detail oriented, and flexible in work schedule availability to meet the demands of a multi-product clinical and commercial phase cellular therapy company.

• Review and approve all 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 Quality subject matter expert for CSA, providing guidance to business system owners, project teams, and QA on compliant, risk-based validation strategies.
• Ensure adherence to FDA regulations (21 CFR Part 11, Part 210/211), GAMP 5, EU GMP Chapter 4, MHRA Guidance, ALCOA++, Audit Trails, and applicable ICH guidelines.
• Review and approval of Data Integrity Assurance program deliverables (User Access Review, Audit Trail Review, Backup Review)
• Work in Res_Q by Sware to manage the full validation lifecycle, ensuring accurate and complete documentation.
• Oversight system Periodic Reviews, ensuring validated state is maintained and documented appropriately.
• Approve test scripts, ensuring appropriate risk-based testing is applied, focusing on critical functionality.
• 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
• Influences hiring, development, and related personnel processes
• Mentoring and professional development of staff.
• Other duties as assigned

• Bachelor’s Degree in Computer Science, Engineering, Life Sciences, or related field.
• Minimum 8 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, EU GMP Chapter 4, MHRA Guidance, ALCOA++, Audit Trails, 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.
• Experience on the Risk assessment approach to support the CSA.
• 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.

• 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)

As an organization, we are committed to creating an environment where everyone ACCTS.