Senior Validation Project Manager

CAI • Portland, OR

4d • $102,100 - $111,700

About The Position

CAI is seeking a technically strong project manager with a background in commissioning, qualification, and validation (CQV) strategy, development, and field execution. The position manages project scope, schedule, and budget and leads teams of engineers and consultants on defined scopes of work. Project experience managing budgets of $1 million or more and teams of at least 6–8 people is sought. Relevant subject-matter expertise may include facilities, clean utilities, upstream and downstream biotech equipment, single-use disposables, or aseptic fill-finish manufacturing.

This is an active, multifaceted role involving activities such as leading budget reviews and daily team huddles, reviewing summary reports, writing protocols, and supporting field execution. The position typically reports to a client manager or area manager. Domestic and international travel may be required, and paid overtime must be accommodated.

CAI is a professional services company established in 1996 with more than 800 people worldwide. It provides commissioning, qualification, validation, start-up, project management, and other consulting services for operational readiness in FDA-regulated and other mission-critical industries. CAI emphasizes client service, integrity, collaboration, respect, and diligent teamwork.

Requirements

• Bachelor’s degree in a science or engineering field, or equivalent experience.
• 8–12 years of experience commissioning and qualifying biopharmaceutical systems, equipment, and systems.
• At least three years serving as a program or project manager for life-science projects with budgets of $1 million or more; comparable experience in other industries will be considered.
• Demonstrated direct responsibility for scope, schedule, and budget on project work.
• Demonstrated success leading teams to achieve defined goals; experience managing teams of at least 6–8 engineers and consultants is sought.
• Excellent ability to lead teams performing complex tasks under pressure.
• Excellent problem-solving skills.
• Proficiency and experience with various project management software tools.
• Customer-service focus.
• Excellent oral and written communication skills in English.
• Able to travel domestically and internationally as required.
• Able to work paid overtime.
• Able to work in the United States without sponsorship now or at any time in the future.

Nice To Haves

• Experience with risk assessments, qualification protocols, commissioning plans or test scripts, and summary reports.
• Experience with CIP/SIP.
• CQV subject-matter expertise in facilities, clean utilities, upstream or downstream biotech equipment, single-use disposables, or aseptic fill-finish manufacturing.
• PMP certification.

Responsibilities

• Manage project scope, schedule, and budget.
• Lead teams of engineers and consultants to deliver defined scopes of work and achieve project goals.
• Lead budget review meetings and daily team huddles.
• Review summary reports and write protocols.
• Support project teams executing work in the field.
• Travel domestically and internationally as required.

Benefits

• 4% retirement contribution.
• 24 days of paid time off and 5 sick days per year.
• Health insurance, described as available at extremely low cost to the employee.
• Financial support for internal and external professional education.
• Company-paid long-term disability; the description specifies 70% long-term disability paid by the company.
• Company-paid life insurance.
• Competitive compensation; the stated average base salary range is $102,100–$111,700 per year, excluding benefits and potential overtime and/or cost-of-living adjustment.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior