Validation Engineer jobs in Santa Ana, CA

Description:

• Support all aspects of the Cleaning Validation Life Cycle for clients from development through qualification and monitoring.

• Create/author/execute at a minimum, Validation Plans, V-cycle documents, Validation Summary Report, Qualification protocols/reports, and Performance Qualification protocols/reports.

• Responsible for the qualification of cleaning manufacturing equipment independently in aseptic filling and GMP areas, including autoclave, Vessel Equipment validation, Sterilization in Place of filling vessels and COP validation in accordance with corporate and departmental procedures.

• Participate in cross-functional project team, including value streams and site support groups to address specific problems, facilitate discussion and research and enable procedures to become more efficient.

• Experience with writing and executing Hold Time studies.

• Experience with gowning in aseptic classified areas.

• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, and standard operating procedures.

• Perform carry-over calculations and determine cleaning limits.

Skills:

Validation, cleaning validation, Pharmaceutical, Process validation, Equipment validation, gmp, Project engineering, report writing, Validation testing, Quality assurance, Software validation, Technical writing, aseptic

Additional Skills & Qualifications:

Bachelor’s degree (B.A./B.S.) of Science in Engineering, Chemistry or related field or equivalent.

Minimum of 3 years experience

Experience Level:

Intermediate Level

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 for other accommodation options.