Senior Quality Validation Engineer

TalentBurst, an Inc 5000 company; Swiftwater (Monroe County); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Job summary

TalentBurst is seeking a Quality Validation Engineer / Validation Specialist for a 12-month contract in Swiftwater, PA. The role requires 6-9 years of experience in highly regulated manufacturing and a strong background in validation and CAPA within life sciences.

The successful candidate will lead CAPA investigations, ensure compliance with FDA/GMP/GxP/QSR, and support validation across equipment, processes, facilities, and computerized systems while collaborating with Quality, Manufacturing,

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; Master's degree preferred.
• 6-9 years of experience in the pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments.
• Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.
• Demonstrated experience leading and managing Corrective and Preventive Action (CAPA) investigations and activities.
• Comprehensive knowledge of Quality System Regulations (QSR), GxP requirements, and industry best practices.
• Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
• Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments.
• Proven ability to collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
• Strong analytical and problem-solving skills with exceptional attention to detail.
• Ability to manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines.
• Excellent verbal and written communication skills, with the ability to present complex information clearly to diverse stakeholders.
• Self-motivated, organized, and capable of working independently in a fast-paced, regulated environment.

Skills

Quality validation

CAPA management

Regulatory knowledge (FDA, GMP, GxP, Q

Cross-functional collaboration

Validation planning & documentation

Education

Bachelor's degree in Engineering or Life Sciences

Master's degree preferred

Job description

TalentBurst is seeking a Quality Validation Engineer / Validation Specialist for a 12-month contract in Swiftwater, PA. The role requires 6-9 years of experience in highly regulated manufacturing and a strong background in validation and CAPA within life sciences.

The successful candidate will lead CAPA investigations, ensure compliance with FDA/GMP/GxP/QSR, and support validation across equipment, processes, facilities, and computerized systems while collaborating with Quality, Manufacturing,