Senior Quality Engineer

Iovance Biotherapeutics, Inc.; Philadelphia (Philadelphia County); On-site; USD 95,000 - 105,000; Full time

Job summary

An established industry player is seeking a Senior Quality Engineer to provide critical oversight in the development of a cutting-edge cGMP cell therapy manufacturing facility. This role involves ensuring compliance with quality standards, leading initiatives to improve data integrity, and collaborating with cross-functional teams to enhance operational efficiency. The ideal candidate will have extensive experience in the biopharmaceutical sector, with a strong focus on quality assurance and regulatory compliance. If you thrive in a dynamic environment and are passionate about contributing to innovative healthcare solutions, this opportunity is perfect for you.

Qualifications

• 8 years of biopharmaceutical experience in a technical role.
• Experience leading GxP Computer System implementation.
• Ability to communicate effectively with management.

Responsibilities

• Provide Quality oversight for cGMP cell therapy manufacturing.
• Support audit and submission activities for regulatory compliance.
• Create and maintain quality documentation and procedures.

Skills

Quality Assurance

Risk Management

Data Integrity

Computer System Validation

cGMP Compliance

Technical Documentation

Interpersonal Communication

Problem Solving

Education

BA/BS in Scientific or Engineering Discipline

Master's Degree

Tools

Microsoft Office Suite

Job description

Join to apply for the Senior Quality Engineer role at Iovance Biotherapeutics, Inc.

2 days ago Be among the first 25 applicants

Join to apply for the Senior Quality Engineer role at Iovance Biotherapeutics, Inc.

Get AI-powered advice on this job and more exclusive features.

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 Senior Quality Engineer will be responsible for supporting the design, installation and evaluation of equipment, utilities, components, products and computer systems while ensuring they are fully operational, effective and free from defects during the entire system lifecycle. Further support the formulation of quality policies, procedures as well as conducting training on quality concepts/tools. In addition, the Senior Quality Engineer will support audit and submission activities for regulatory compliance.

Essential Functions and Responsibilities

• 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.
• Supporting the oversight of Data Integrity and Computer System Validation efforts, system lifecycle and improvements for laboratory and manufacturing systems, enterprise applications and infrastructure.
• Supporting cGMP quality improvement efforts at iCTC (Philadelphia, PA) and in remote facilities such as IOVA-A (Philadelphia, PA).
• Providing Quality oversight of system change management, requirements, configurations, detailed designs, technical specifications and test scripts.
• Creating and maintaining company documentation, such as quality manuals, and quality procedures.
• Applying good manufacturing practice and observing that it is being adhered to.
• Represent Quality on cross-functional teams to complete projects, address quality issues and implement quality system improvements.
• Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes and disposition of discrepant material.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

Required Education, Skills, and Knowledge

• BA/BS degree in scientific or engineering discipline.
• A minimum of 8 years of biopharmaceutical industry experience in a technical or supporting technical role with Bachelor’s degree; or 6 years and a Master’s degree.
• A minimum of 5 years leading or supporting GxP Computer System implementation and validation.
• Demonstrable experience creating and utilizing manufacturing and laboratory testing systems.
• Ability to comprehend technical design and specification documents for software systems and applications.
• Strong experience developing and executing protocols for single-use process systems, lab systems and software applications in a cGMP environment
• Demonstrable experience creating and maintaining policies, processes and procedures for a new cGMP facility
• Demonstrable experience utilizing risk-based assessments and setting up lifecycle verification programs for manufacturing and laboratory systems.
• Ability to effectively communicate with management and project team members.
• Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results.
• Strong professional interpersonal and communications skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders.
• Ability to meet deadlines and multi-task efficiently.
• Must be comfortable in a fast-paced environment with minimal direction and changing priorities.
• Experience identifying changes, driving improvements, and streamlining processes required.
• Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project.

Preferred Education, Skills, and Knowledge

• A minimum of 2 years experience in a Quality role is highly desirable.
• Experience in preparing for and participating in regulatory inspections to ensure successful outcomes.

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 remain in a stationary position standing or sitting for prolonged periods of time.
• 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.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

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

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Iovance Biotherapeutics, Inc. by 2x

Get notified about new Quality Engineer jobs in Philadelphia, PA.

Manufacturing / Industrial Engineer - Mid-Career

Quality Engineer / Plant Operations (Job Number: 1144)

Senior Quality Engineer/ Plant Operations (Job Number: 1145)

Warminster, PA $95,000.00-$105,000.00 1 month ago

Specialist, Supplier Quality Engineering

Sr Specialist, Quality Engineering-Supplier Quality

Supplier Quality Mgr (Supplier Quality Leadership)

Quality Assurance Engineering Specialist

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.