Senior Quality Engineer

ZipRecruiter; Philadelphia (Philadelphia County); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player seeks a Senior Quality Engineer to ensure quality oversight in a cGMP cell therapy manufacturing environment. This role involves supporting the design, installation, and evaluation of critical systems, ensuring they are effective and defect-free. You will lead initiatives for quality improvement, collaborate with diverse teams, and maintain documentation to meet regulatory standards. If you thrive in fast-paced settings and have a passion for quality assurance, this opportunity offers a chance to make a significant impact in a growing field.

Qualifications

• 8+ years in biopharmaceutical industry with Bachelor's or 6 years with Master's.
• 5 years supporting GxP Computer System implementation and validation.

Responsibilities

• Identify risks and develop mitigation strategies with cross-functional teams.
• Oversee Data Integrity and Computer System Validation efforts.

Skills

Quality Assurance

GxP Computer System Validation

Risk Assessment

Technical Documentation

Interpersonal Communication

Process Improvement

Microsoft Office Suite

Education

BA/BS in Scientific or Engineering Discipline

Master's Degree in Relevant Field

Job description

Overview

The Senior Quality Engineer, Quality Assurance Engineering, will provide quality 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 role involves supporting the design, installation, and evaluation of equipment, utilities, components, products, and computer systems, ensuring they are fully operational, effective, and defect-free throughout their lifecycle. Additionally, the Senior Quality Engineer will support the formulation of quality policies, procedures, and conduct training on quality concepts/tools. The role also includes supporting audit and submission activities for regulatory compliance.

Essential Functions and Responsibilities

1. Identify risks, develop mitigation strategies, and resolve issues collaboratively with cross-functional teams such as Manufacturing, Quality Control, IT, Engineering, and Validation.
2. Oversee Data Integrity and Computer System Validation efforts, system lifecycle, and improvements for laboratory and manufacturing systems, enterprise applications, and infrastructure.
3. Support cGMP quality improvement initiatives at iCTC (Philadelphia, PA) and remote facilities like IOVA-A (Philadelphia, PA).
4. Provide quality oversight of system change management, requirements, configurations, detailed designs, technical specifications, and test scripts.
5. Create and maintain company documentation, including quality manuals and procedures.
6. Ensure adherence to good manufacturing practices.
7. Represent Quality on cross-functional teams to complete projects, address quality issues, and improve quality systems.
8. Provide technical guidance on quality engineering activities, including root cause analysis, addressing component quality issues, complaint evaluations, corrective actions, product/process changes, and disposition of discrepant material.
9. Adhere to Iovance Biotherapeutics' core values, policies, procedures, and ethics.
10. Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• BA/BS in a scientific or engineering discipline.
• At least 8 years of biopharmaceutical industry experience with a Bachelor's degree, or 6 years with a Master's degree.
• Minimum of 5 years supporting GxP Computer System implementation and validation.
• Experience creating and utilizing manufacturing and laboratory testing systems.
• Ability to understand technical design and specification documents for software systems.
• Experience developing and executing protocols for process systems and software applications in a cGMP environment.
• Experience creating and maintaining policies and procedures for a new cGMP facility.
• Experience with risk assessments and lifecycle verification programs for manufacturing and laboratory systems.
• Effective communication skills with management and project teams.
• Ability to collaborate across organizations and manage professionals to achieve results.
• Strong interpersonal and communication skills, both verbal and written.
• Ability to meet deadlines and multitask efficiently.
• Comfortable in fast-paced environments with minimal supervision and changing priorities.
• Experience in driving improvements and streamlining processes.
• Proficiency with Microsoft Office Suite.

Additional Experience

• Preferred: 2+ years in a Quality role.
• Experience preparing for and participating in regulatory inspections.

Physical and Work Environment

Must be able to remain stationary for prolonged periods, move within the office and lab, exert up to 10 pounds of force, have visual acuity for data analysis, perform repetitive motions, and communicate effectively. The work environment includes office and manufacturing lab settings with potential exposure to hazards such as chemicals, noise, and lab equipment.

Other Considerations

This role requires clear thinking, good judgment, troubleshooting, problem-solving, and the ability to handle stress and multiple priorities. Reasonable accommodations can be made upon request.

Equal Opportunity Statement

Iovance is committed to diversity and inclusion. We consider all applicants without regard to protected characteristics. For assistance or accommodations, contact [e-mail].

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