Job Title: QA ValidationJob Description The QA Validation Associate will provide Quality Engineering oversight and support for the development and operations of a commercial scale cGMP cell therapy manufacturing and laboratory facility along with associated software applications. This Quality Assurance Engineering Specialist will be responsible for supporting the design, installation, and evaluation of GMP equipment, system utilities, components, products, and computer systems while ensuring they are fully operational, effective, and free from defects during the entire system lifecycle. Further support the formulation of quality policies, procedures as well as conducting training on quality concepts/tools. In addition, the Quality Assurance Engineering Specialist will support audit and submission activities for regulatory compliance. - Identifying risk, developing mitigation strategies, alternative solutions, resolving issues, in collaboration with cross-functional groups such as Manufacturing, Quality Control, IT, Supply Chain, Engineering, and Validation. - Supporting cGMP quality improvement efforts local site in Philadelphia, PA, and in remote facilities such as their other site in Philadelphia, PA, and the Tampa Labs (Tampa Bay, FL). - Creating and maintaining company documentation, such as quality manuals, validation protocols, Standard Operating Procedures, and Work Instructions. - Applying good manufacturing practice and observing that it is being adhered to. - Represent Quality on cross-functional teams to complete projects, address quality issues, and implement quality system improvements. - Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes, and disposition of discrepant material. Hard Skills + Quality Engineering oversight + GMP equipment design and installation + System lifecycle management + Quality policy formulation + Audit and regulatory compliance support + Documentation creation and maintenance + Root cause analysis investigations Soft Skills + Risk identification + Mitigation strategy development + Cross-functional collaboration + Technical guidance + Quality issue resolution Job Type This is a permanent position. Work Site This is a fully on-site position in Philadelphia, Pennsylvania. Work Environment This is primarily an office-based role. 80% of the work will be done in office, open to 1 day work from home. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.