Senior Validation Project Manager

CAI • Portland, OR

3d

About The Position

CAI project managers are technical leads with strong backgrounds in commissioning, qualification, and validation (CQV) strategy, development, and field execution. The role involves direct responsibility for scope, schedule, and budget, and typically includes managing projects of $1 million or more and teams of at least 6–8 engineers and consultants. Project managers are active, multifaceted contributors who may lead budget reviews and daily team huddles, review summary reports, write protocols, and support field execution. Relevant subject-matter expertise may include facilities, clean utilities, upstream and downstream biotech equipment, single-use disposables, or aseptic fill-finish manufacturing. The role typically reports to a client manager or an area manager and requires domestic and international travel as needed. CAI is a professional services company established in 1996 with more than 800 people worldwide, providing commissioning, qualification, validation, start-up, project management, and other consulting services for operational readiness in FDA-regulated and other mission-critical industries.

Requirements

• Bachelor of Science in a science or engineering field, or equivalent experience.
• 8–12 years of experience commissioning and qualifying biopharmaceutical systems and equipment.
• At least three years serving as a program or project manager for life-science projects with budgets of $1 million or more; similar 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, including teams of at least 6–8 engineers and consultants.
• Excellent team leadership skills, including the ability to lead complex tasks under pressure.
• Excellent problem-solving skills.
• Proficiency and experience with project-management software tools.
• Customer-service focus.
• Excellent oral and written communication skills in English.
• Ability to work paid overtime.
• Ability 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

• Lead CQV strategy, development, and field execution as a technical project lead.
• Manage project scope, schedule, and budget, including projects with budgets of $1 million or more.
• Lead teams of engineers and consultants to deliver defined scopes and achieve project goals.
• Lead budget review meetings and daily team huddles.
• Review summary reports and write protocols.
• Support the team in field execution.
• Travel domestically and internationally as required.

Benefits

• 4% retirement contribution.
• 24 days of paid time off and 5 sick days per year.
• Health insurance at extremely low cost to the employee.
• Financial support for internal and external professional education.
• Company-paid long-term disability coverage, described as 70% in the benefits text.
• Company-paid life insurance.
• Competitive compensation.
• Potential overtime and/or cost-of-living adjustment.

What This Job Offers

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