Quality Validation Engineer III

Job Title: Quality Validation Engineer III

Location: Swiftwater, PA (on-site)

Type: Contract (W2)
Term: 12-months

Schedule: Monday - Friday; 9 AM - 5 PM

Pay Rate Max: $98 per hour

Sanofi's contingent workforce program, FLEXT Direct, is seeking a Quality Validation Engineer III for a 12-month contract.

We are seeking a highly skilled and experienced quality and validation professional to join a dynamic team within a fast-paced, regulated life sciences manufacturing environment. This role is central to ensuring that all manufacturing processes, equipment, facilities, and systems meet the highest standards of quality, compliance, and regulatory integrity. The ideal candidate brings deep expertise in quality systems, validation methodologies, and regulatory frameworks, and thrives in a collaborative, cross-functional setting where precision, accountability, and continuous improvement are paramount.

Responsibilities:

• Lead and manage Corrective and Preventive Action (CAPA) investigations, ensuring timely identification of root causes and implementation of effective corrective measures

• Support and oversee validation activities including equipment qualification, process validation, facility validation, computerized system validation, and associated documentation review

• Ensure ongoing compliance with Quality System Regulations (QSR), GxP requirements, FDA guidelines, and applicable industry best practices

• Conduct thorough risk assessments and root cause analyses to address quality deviations and non-conformances

• Collaborate cross-functionally with Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs teams to drive quality initiatives and resolve compliance issues

• Develop, review, and approve technical documentation including validation protocols, reports, SOPs, and quality records

• Monitor and support high-speed aseptic filling operations and sterile manufacturing processes to maintain product integrity and regulatory compliance

• Manage multiple concurrent projects, balancing priorities to meet aggressive timelines and strict regulatory deadlines

• Champion continuous improvement initiatives and quality excellence programs across the organization

• Present complex technical and compliance information clearly and effectively to diverse stakeholders at all organizational levels

Skills:

• Quality Validation and Compliance

• CAPA Management and Oversight

• Regulatory Knowledge spanning FDA, GMP, GxP, and QSR frameworks

• Risk Assessment and Root Cause Analysis

• Cross-Functional Collaboration and Stakeholder Engagement

• Project Management and Prioritization

• Technical Documentation and Reporting

• Continuous Improvement and Quality Excellence

• Strong analytical thinking with exceptional attention to detail

• Excellent verbal and written communication skills

Experience:

• 6 to 9 years of experience in pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments

• Demonstrated experience leading CAPA investigations and managing quality system activities

• Proven background in quality validation, quality systems, and regulatory compliance within the life sciences industry

• Experience supporting validation activities across equipment, processes, facilities, and computerized systems

• Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments

• Proven ability to work independently and manage multiple projects simultaneously in a fast-paced regulated setting

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required

• Master's degree in a relevant field is preferred

This is a remarkable opportunity to take on a high-impact role at the intersection of quality, compliance, and innovation within a cutting-edge life sciences manufacturing environment. You will have the chance to shape critical quality systems, influence regulatory strategy, and collaborate with some of the brightest minds in the industry — all while contributing to the development and delivery of products that make a meaningful difference in patients' lives. If you are a driven, detail-oriented professional with a passion for quality excellence and regulatory integrity, this role offers the challenge, visibility, and growth potential you have been looking for.

Salary : $98