<p>Overview</p> <p>The Quality Engineer will support the Quality organization in the day-to-day manufacturing and oversight of all validation, commissioning, and other technical activities at Iovance. The Quality Assurance Engineer will work cross functionally with Facilities Engineer, Process Engineer, Validation Engineering, Manufacturing, IT, and MSAT to ensure adherence to our SOPs and cGMP requirements. The Quality Engineer will collaborate on, review, and approve documentation including but not limited to: SOPs, validation lifecycle documents, quality documents (CAPAS, CCRs, and DRs), work orders, and engineering documentation. ?In addition, the Quality Engineer will support audit and submission activities for regulatory compliance.</p> <p>This individual will support all products from clinical programs through commercial stage products. The candidate has a demonstrated ability to work and collaborate effectively with a team to achieve consistently positive results.</p> <p>Essential Functions and Responsibilities</p> <ul> <li>Identifying risk, developing complex mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups such as Manufacturing, Quality Control, IT, Engineering and Validation </li><li>Supporting cGMP quality improvement efforts at iCTC (Philadelphia, PA) and in remote facilities such as IOVA-A (Philadelphia, PA) and the Tampa Labs (Tampa Bay, FL). </li><li>Provide oversight and Quality Assurance Engineering technical support as a subject matter for commissioning, validation, facilities, and metrology and equipment and system qualifications and their reliability and compliance. </li><li>Partner with team members across the organization to ensure compliant Validation, Engineering, and IT activities to support clinical and commercial manufacturing are completed and running in compliance with cGMP. </li><li>Collaborate closely with Engineering, Manufacturing, IT, QC and Regulatory Affairs to build an effective Validation program for the internal manufacturing facility. </li><li>Support other Quality Assurance functions such as Document Control, QA Operations and Quality Systems as needed. </li><li>Review and approve validation lifecycle documents including Change Records, Technical Deviations, Exceptions, CAPA's, design revisions, SOPs, and various engineering protocols from basis of design to commissioning (SAT, FAT and Turn Over Packages). </li><li>Live the company values by example including Iovance Quality mindset principles. </li></ul> <p>Travel: Less than 10%</p> <p>Required Education, Skills, and Knowledge</p> <ul> <li>2+ years of biopharmaceutical industry experience in a technical or supporting technical role </li><li>2+ years leading or supporting GxP System implementation and validation </li><li>Bachelor of Science in Engineering or comparable life science degree. </li><li>Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project </li><li>Experience with quality systems such as deviations, change control, and CAPAs required. </li><li>Strong professional interpersonal and communications skills, both verbal and written, for providing clear direction for the business, vendors, and internal stakeholders. </li><li>Ability to meet deadlines and multi-task efficiently. </li><li>Must be comfortable in a fast-paced environment with minimal direction and changing priorities. </li><li>Proven ability to support and encourage cross functional collaborative work environment. </li><li>Proven ability to work independently with limited guidance. </li></ul> <p>Preferred Education, Skills, and Knowledge</p> <ul> <li>2+ years of experience in a Quality role is highly desirable </li><li>Experience with Master Control or comparable GMP document management system preferred </li><li>Experience with Blue Mountain RAM or comparable asset management system preferred </li></ul> <p>The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.</p> <p>Physical Demands and Activities Required</p> <ul> <li>Must be able to remain in a stationary position standing or sitting for prolonged periods of time. </li><li>Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. </li><li>Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. </li><li>This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. </li><li>Must be able to communicate with others to exchange information. </li></ul> <p>Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines</p> <p>Work Environment</p> <p>This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards.</p> <p>The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.</p> <p>Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.</p> <p>By voluntarily providing information and clicking "Submit Application", you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.</p> <p>#LI-onsite</p>