Senior Validation Engineer

CAI; Los Angeles (CA); On-site; USD 87,000 - 95,000; Full time

Job summary

Join a dynamic and employee-owned company that prioritizes client interests and fosters a culture of integrity and teamwork. As a Validation Process Engineer, you will play a crucial role in developing documentation for the commissioning and validation of pharmaceutical facilities. This position offers the opportunity to lead small teams and tackle technical challenges in a regulated industry. With a commitment to employee success and professional growth, this role provides competitive compensation, generous PTO, and robust benefits, making it an exciting opportunity for those looking to make a significant impact in their field.

Benefits

15% retirement contribution

24 days PTO

5 sick days

Low-cost health insurance

Support for professional education

70% long-term disability paid by the company

Qualifications

• 4-16 years of experience in commissioning and qualification activities.
• Ability to work independently and build project teams.

Responsibilities

• Develop documentation for commissioning, qualification, and validation.
• Plan and coordinate work, directing small teams in document execution.

Skills

Technical problem-solving

Troubleshooting skills

Attention to detail

Multi-tasking

Microsoft Word

Microsoft Excel

Education

BS in relevant science or engineering

Equivalent hands-on experience

Tools

Delta V

Control Systems

ISPE Baseline Guide 5

Job description

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Position Description

The Validation Process Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. Responsibilities include protocol writing and execution (field verification), and development of summary reports at client sites. Additional duties involve planning and coordinating work, as well as directing small teams in document development and execution.

Requirements Include

• BS in a relevant science or engineering field, or equivalent hands-on experience
• 4-16 years’ experience performing commissioning and/or qualification activities in a regulated industry
• Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
• High attention to detail
• Ability to multi-task, take initiative, and meet deadlines
• Ability to work independently and build project teams
• Expertise in Microsoft Word and Excel
• Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
• Experience with Delta V, Control Systems, or planning/directing C&Q activities a plus

Other Requirements

• Excellent oral and written English
• Ability to travel domestically and possibly internationally
• Willingness to work paid overtime
• Legal ability to work in the US without sponsorship now or in the future

About CAI

CAI is a 100% employee-owned company established in 1996, with over 800 employees worldwide. We provide commissioning, qualification, validation, start-up, project management, and consulting services for FDA-regulated and other mission-critical industries.

Are You Ready?

Our approach: put the client’s interests first, do not stop until it is right, and do whatever it takes to succeed. We are committed to living our core principles: acting with integrity, serving each other and society, and working for our future. Employee ownership fosters team success, respect, and a can-do attitude.

Benefits

Competitive compensation and benefits, including up to 15% retirement contribution, 24 days PTO, 5 sick days, low-cost health insurance, support for professional education, and 70% long-term disability paid by the company.

Salary: $87,100 - $94,600 per year, excluding benefits, overtime, or COLA.

We are an equal opportunity employer, promoting diversity and inclusion, and consider qualified applicants with criminal histories in accordance with applicable laws.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Pharmaceutical Manufacturing