Job Title: Quality Validation Engineer

Job Description

The Quality Validation Engineer is responsible for validation documentation of equipment, processes, methods, and software, including Master plans, IQ/OQ/PQ, and Final Reports. The role involves executing validation protocols and writing final reports. The engineer understands the Quality System Regulations and ISO standards and facilitates improvements. They will oversee quality control in product design and the manufacturing process, support R&D and Operations during product development phases, and develop process qualification activities, statistically sound sampling plans, and process control plans, including inspection/test method development.

Responsibilities

• Develop and maintain validation documentation of equipment, processes, methods, and software.

• Execute validation protocols and write final reports.

• Understand and apply Quality System Regulations and ISO standards.

• Facilitate improvements in quality control processes.

• Support R&D and Operations during all product development phases.

• Develop process qualification activities and statistically sound sampling plans.

• Create process control plans, including inspection/test method development.

Essential Skills

• Experience with ISO standards and Quality System Regulations.

• Proficiency in validation, including IQ/OQ/PQ protocols.

• Effective risk assessment and risk analysis skills.

• Experience with QMS, CAPA, and root cause analysis.

• Proficiency in validation protocols, quality assurance, regulatory compliance, and GMP.

• Familiarity with automation and Minitab.

Additional Skills & Qualifications

• BS Degree in a relevant field.

• 2-5 years of experience in a Quality Validation role.

• Knowledge of Good Manufacturing Practices (GMPs) and Quality Systems.

• Experience with validation documentation and execution of protocols.

• ASQ Certified Quality Engineer preferred.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.