Process Engineer I

Iovance Biotherapeutics is seeking a Process Engineer to join the team. This engineer is responsible for providing oversight and review of design and construction work related to process improvements within a cGMP manufacturing facility.

Incumbent will support the startup, CQV (Commissioning, Qualification and Validation) of process equipment as well as the development of process technical transfer documents. This role will Interface with senior leadership to develop long term strategic planning consistent with operational strategies as it relates to process, facility engineering and controls.

Essential Responsibilities

• Implement process improvements including the selection and modification of new equipment and facilities.
• Write, review, and edit technical documents, including drafting and approval of Equipment Specification, Test Protocols, SOPs, CAPAs, Change Controls, etc. Perform basic revisions as needed to accurately reflect current procedures. Review and edit documents created by other team members for accuracy, clarity, and consistency.
• Participate in technology transfer, conference calls, and sharing of technical information.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Ensure that all documentation is compliant with internal requirements, regulatory requirements, including FDA, EMA, and ISO standards.
• Attends the weekly management meeting to discuss timelines and weekly priorities.
• Manage projects to ensure timely initiation and completion of work.

Education and Qualifications 

• BS or MS in Chemical, Mechanical, Biochemical Engineering or related degree is required.
• 2+ years of related BioPharma Life Sciences experience required. Preferred experience includes process simulation, preparation and checking of process deliverables, participation in design safety reviews and HAZOPs. Both owner and A&E firm experience will be considered equally.
• Experience with GMP procedures is desired, including change controls, deviation management and CAPAs.
• Extensive knowledge of small-scale cell culture processes and techniques is preferred.
• Prior experience in cell therapy and aseptic manufacturing is highly desirable.
• Experience interfacing with other design disciplines including automation, facility design and mechanical design groups.
• Experience interfacing with CQV and operations teams is required.
• Excellent oral and written communication skills 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.

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:

• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
• Must be able to use near vision to view samples at close range
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 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.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

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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.

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