Job Title: Validation Engineer

Responsibilities

• Test and evaluate new and existing products of moderate to advanced complexity.

• Interpret data and evaluate product performance to verify product packaging requirements and design inputs.

• Execute and assist with the development of verification and validation protocols for medical device product packaging.

• Issue reports for regulatory audits, submissions, and requests.

• Create accurate and thorough documentation that records all steps taken and all measurements used through the verification and validation lifecycle.

• Analyze test results and contribute to design and failure investigations.

• Determine the root cause of defects, safety risks, and performance problems.

• Provide a risk assessment, identify mitigating factors, and check for adherence to regulatory standards.

• Assist with test method development activities including test fixture design, equipment acquisition, and hardware/software validation.

• Focus on device packaging methods related to sterility, seal strength, and material level properties per ISO standards.

• Collaborate with design and development teams to develop product requirements based on user needs, regulatory strategy, and applicable standards.

• Manage assigned projects, establish appropriate timelines, and ensure that deadlines/project goals are met.

Essential Skills

• Experience with equipment validation in the medical device or pharmaceutical industry.

• Knowledge of IQ, OQ, PQ validation protocols.

• Familiarity with process validation and cleaning validation.

• Understanding of ISO standards related to medical device packaging.

• BA degree in an engineering field.

• 3+ years of equipment validation experience.

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.