Validation Specialist

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 Turning 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.

Prepare and execute equipment qualification plans and protocols. Write Final Summary Reports that summarize executed qualifications/validations. Assist in the development, coordination, and execution of qualifications/validation protocols for systems governed by regulations as applicable in the pharmaceutical industry. Coordinate validation related activities in regards to equipment and processes being deployed in GMP environments.

• Develop and execute equipment qualification protocols for all manufacturing, processing, and filling equipment and facilities/utilities supporting these operations.
• Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.
• Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw material certificates of analysis.
• Investigate and resolve deviations/exceptions from the predefined acceptance criteria.
• Draw conclusions from data, observations, deviation/exception and investigation as to whether process is considered valid. 
• Review calibration/qualification records supplied by third party vendors.
• Authors and reviews department SOP’s
• Authors, Reviews and executes User/Functional Requirements Specifications (URS FDS), Risk Assessments (RA), Design Qualification (DQ), Qualification Test Protocols (IQ/OQ/PQ) 
• Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.
• Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.
• Ensure protocols, verifications, validation plans and summary reports generated during validation/ qualification activities are stored according to procedure.
• Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company. Work proactively to maintain the highest level of compliance in all areas. Gather current knowledge from QA/QC, regulatory, periodicals and/or appropriate training programs.

Develop and execute cleaning validation/verification protocols for manufacturing and processing equipment.

• Perform proper and timely sampling of in-process/intermediate products, finished products, rinse water and surface swabbing for testing as outlined by validation/qualification protocols.
• Perform physical testing from representative samples.
• Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA and QC to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.
• Moderate involvement in audits
• Moderate involvement in customer relations
• Other duties as assigned

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What you bring to the team.

• B.S. Degree in Chemical / Biochemical / Biomedical Engineering, Biological Sciences or equivalent combination of Bachelor’s degree and pertinent progressive experience in pharmaceuticals or other highly regulated industry
• Prior experience in validation, with particular knowledge of 21 CFR Part 210 and 211 preferred
• Experience in 21 CFR Part 11 desired
• Ability to communicate clearly with diverse group of team members
• Ability to drive project forward with collaboration
• Knowledge of Statistical software and calculations.
• Knowledge of analytical and process equipment, SCADA control system.
• Strong understanding of cGMPs and validation/qualification concepts.
• Ability to read, program, troubleshoot PLC Ladder Logic and HMI software.
• Ability to analyze pharmaceutical processes to determine critical parameters and critical quality attributes and design testing in the form of protocols to ensure robust and repeatable process. Must have in-depth knowledge of equipment set-up and operation, facility qualifications, master validation policies and protocol generation, and protocol execution.
• Ability to perform qualification and validation reporting.
• PC proficiency using Microsoft Office suite.
•  Excellent written and verbal communication skills.
• Highly organized and detailed.
• Ability to read and comprehend written technical procedures, as-built drawings, P&IDs, blueprints as well as cGMP and SOPs.
• Ability to accurately perform mathematical calculations required by work assignments.
• Must be skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment.

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)

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the workof employees under his/her supervision.

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.