Quality Assurance Validation Specialist

About Minaris Advanced Therapies

Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market.

At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time.

Job Title

Quality Assurance Validation Specialist

Company

Advanced Therapies LLC d/b/a Minaris Advanced Therapies (Philadelphia, Pennsylvania) 400 Rouse Boulevard Philadelphia, PA 19112

Duties

• Serve as primary resource for the review and approval of equipment/software validations (including the IQ, OQ, PQ, and Computer Software Validation IOPQ), System Life Cycle Documentation (Validation Plans, Design Specifications, Requirements Specifications, User Requirements etc.), Change Controls, Action Items, OOTs/Investigations etc., in accordance with industry guidelines (FDA, EU, ICH, ISPE, GAMP, ISO, etc.).
• Provide guidance for equipment/software related issues and consults with QA Management to resolve complex quality issues in a timely manner.
• Provide quality review and/or approval of validation project plans that support site priorities and validation activities associated with changes to new and existing systems.
• Determine the acceptability of testing results against pre-determined criteria through review of data.
• Perform quality review approvals of Change Requests related to introduction of equipment and changes to the qualified state of equipment.
• Partner with application owners and system implementation teams to ensure CFR Part 11 compliance, if applicable, providing consultation and support to meet project goals and objectives.
• Write, review, or approve Periodic Reviews.
• Champion site and regulatory standards and provide guidance through the validation life cycle to ensure adherence to current regulatory standards.
• Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (i.e.: ICH, ISPE, GAMP, ISO, etc.).
• Issue, review, or approve document change requests, SOPs, IQ/OQ/PQ protocols, and other applicable documentation.

Requirements

• Bachelor’s degree or foreign equivalent in Biomedical Engineering, Chemical Engineering, or a closely related field and 3 years of experience in the position offered or related.
• Must have 3 years of experience with: writing, reviewing, and/or approving equipment and software validations including IQ, OQ, PQ and CSV-IOPQs; applying knowledge of 21 CFR Part 11 and ISPE GAMP 5; applying knowledge of GLP and cGMP requirements, guidelines, and ISO requirements; applying knowledge of relevant GXP (Good Practice), including FDA and EU and other regulatory bodies as well as guidance documents including ICH, ISPE, GAMP, and ISO; working with laboratory/manufacturing/facility staff to provide expertise on equipment/software validations and address conditions/practices with appropriate personnel; and writing, reviewing, and/or approving Change Controls and issuing, reviewing, and/or approving document change requests.

Send resume to Advanced Therapies LLC at PHLHumanResources@minaris.com and reference position title in subject line.

Benefits

Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.