C

CAI

Operational readiness consulting for pharma

Senior Validation Project Manager

Project ManagementConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A BS in a science or engineering field, or equivalent experience.
  • 8–12 years of experience commissioning and qualifying bio-pharma systems, equipment, and systems.
  • Three or more 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.
  • Direct responsibility for scope, schedule, and budget on project experience.
  • Experience managing projects of $1 million or more and teams of at least 6–8 engineers and consultants on defined scopes of work.
  • Excellent skill in leading teams to perform complex tasks under pressure.
  • Excellent problem-solving skills.
  • Proficiency and experience with various project management software tools.
  • 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.

Responsibilities

  • Lead budget review meetings and daily team huddles.
  • Review summary reports.
  • Write protocols.
  • Support the team executing in the field.

Desired Qualifications

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

About the Company

CAI

Operational readiness consulting for pharma

CAI Technical Consulting Malaysia SDN (brand cagents.com) provides operational readiness consulting for pharmaceutical, biotech, and healthcare firms. It helps clients prepare for full-scale production through quick operational readiness assessments, gap-tailored plans, and hands-on implementation support in areas like project planning, production operations, asset management, reliability, and sustainability, plus Digital Pathology Validation for Leica Biosystems to meet regulatory standards. The firm differentiates itself by combining rapid assessments with practical, cost-effective strategies, ongoing industry collaboration, and global delivery that informs tailored solutions. Its goal is to help clients accelerate their path to compliant, scalable operations and successful production scale-up.

Company size
1,001-5,000
Company stage
Pre-seed
Total funding
$3.4M
Headquarters
Indianapolis, IN
Founded
1996

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