Compliance Engineer

Iovance is hosting an onsite Job Fair.
Where: Iovance Cell Therapy Center (iCTC)
Location: 300 Rouse Blvd Philadelphia, PA 19112
Date: Wednesday, October 23, 2024
Time: 12pm to 6pm (EDT)
What to bring: Updated hard copy resume
We are Hiring! We look forward to seeing you at the Job Fair.
Overview
The Compliance Engineer ensures that Iovance's manufacturing processes comply with the governing regulations. This role supports various departments at the site facility by engaging in investigations, reviewing documents and SOPs, governing Change Control Requests (CCR), and completing gap analysis on our various systems to ensure quality standards.
Location:
700 Spring Garden Street
Philadelphia, Pennsylvania
19123
Essential Functions and Responsibilities
The Compliance Engineer shall be responsible for supporting the Technical Operations team with the following responsibilities:

• Managing investigations related to engineering systems, the manufacturing facility and supporting equipment. This includes gathering data for investigations, writing reports, and coordinating meetings with all the affected parties.
• Identify root causes and corrective actions related to equipment failures.
• Track and manage timely completion of CAPAs (Corrective and Preventive Actions) that result from investigations and audits.
• Generate and review CCRs (Change Control Requests) related to engineering systems and projects as applicable.
• Perform gap analysis on engineering systems regarding Quality Standards.
• Provide technical support to Engineering colleagues on Compliance issues.

Required Education, Skills, and Knowledge

• BS in a scientific discipline
• 2+ years of related BioPharma Life Sciences experience required.
• Experience with GMP procedures is required, including change controls, deviation management and CAPAs.
• Experience interfacing with CQV, maintenance and operations teams is required.
• Must have strong analytical, communication, presentation and interpersonal skills.
• Exceptional attention to detail and follow through.
• Effective technical presentation skills.
• Excellent verbal and written skills in communicating regulatory and technical information.

Preferred Education, Skills, and Knowledge

• Chemical, Mechanical, Biochemical Engineering or related degree is preferred.
• Knowledge of small scale cell culture processes and techniques is preferred.
• Prior experience in cell therapy manufacturing is highly desirable.

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.
Physical Demands and Activities Required:

• Able to stand and/or walk 10% (and sit 90%) of a 10-hr day which may include climbing ladders or steps.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 25 pounds.

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 deadline

Work Environment:

• This position will work in both an office and a manufacturing lab setting.
• Potential exposure to noise and equipment hazards and strong odors.

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.
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
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