Overview
The Validation Engineer I is responsible for supporting the qualification of the CGMP cell therapy manufacturing facility for Iovance. This position is responsible for the development and execution of validation testing and documentation for a variety of equipment, utilities, components, products, and systems.
Reporting to the Associate Director, Validation Engineering, the individual works internally across the Iovance organization to administer and continuously improve the site’s validation system. They will assist with the management of contract staff and project resources. They are required to act on problems of diverse and highly technical scope, requiring critical thinking and interaction with internal and external technical professionals. They ensure contract resources adhere to schedules and performance requirements in qualification of the new cell therapy facility and continuous validation. They exercise broad judgment within generally defined practices and policies and will exercise analytical decision-making abilities.
Ensuring timely execution of all re-validation requirements through accurate requirements definition; authoring, executing, and summarizing commissioning and qualification protocols for GXP systems including equipment/test instruments, utilities, processes, and facility systems; assisting with the coordination of investigations, impact assessment, and resolution for validation and re-validation non-conformances; maintaining and reporting applicable department and system metrics; supporting capital project teams by defining and coordinating commissioning and qualification requirements; providing general technical advice on new equipment and modification to existing equipment to ensure that validation and qualification status is maintained in a state of control; and proactively identifying, assessing, and mitigating operational and organizational risks, and escalating key risks and issues products.
Essential Functions and Responsibilities:
• Support for qualification and / or validation for systems and systems associated to iCTC cGMP capital projects
• Maintain periodic review of critical systems.
• Generate and execute validation protocols using Good Documentation Practices (GDPs)
• Investigate and resolve protocol exceptions or discrepancies
• Develop technical reports and validation summary reports
• Read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs, etc.). Perform or facilitate design qualification
• Develop Standard Operating Procedures (SOPs), User Requirement Specifications, and other regulatory support documentation
• Perform risk assessments and impact assessments
• Assist with the Management validation contractor services during qualification of new facility and validation maintenance of critical systems.
• Expertise in FDA, PIC/S, and ICH qualification and validation requirements and creative risk- based approaches for meeting and exceeding the minimum requirements
• Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support the project
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
• Bachelor’s degree in Life Sciences, Engineering or equivalent.
• 1-3 years of relevant operations experience for successful validation experience in the pharmaceutical or biotech industry including validation leadership positions on major cGMP capital projects.
• Demonstrable experience creating and utilizing systems for monitoring and controlling the execution of validation functions.
• Strong experience developing and executing validation protocols for Facilities, Utilities, Systems, Equipment, EMPQ, and Aseptic Process Validation in a CGMP environment
• Demonstrable experience maintaining validation policies, processes, and procedures for a new cGMP facility
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
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.
Preferred Education, Skills, and Knowledge
• Experience with cell therapy products
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 lab and clean room attire as well as all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Able to stand and/or walk 90% (and sit 10%) of the scheduled workday 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 deadlines.
Work Environment:
This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.
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 do not constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the position’s duties 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 careers@iovance.com
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