Full-Time

Operational Readiness Project Manager

Updated on 5/7/2026

CAI

CAI

501-1,000 employees

Operational readiness consulting for pharma

Compensation Overview

$140k - $175k/yr

No H1B Sponsorship

Indianapolis, IN, USA

Hybrid

Hybrid role; travel domestically and internationally may be required.

Category
Business & Strategy (1)
Required Skills
Risk Management
Data Analysis
Requirements
  • BS or MS in a relevant science or engineering field (or equivalent).
  • 3+ years as a program/project manager on life science projects ($1MM+) or 8+ years in GMP-regulated operations with 5+ years leading readiness/start-up/operational excellence transformations.
  • Black Belt or equivalent certification preferred.
  • Proven multi-site or multi-client portfolio experience.
  • Deep understanding of quality systems, technology transfer, equipment qualification, and analytics.
  • Excellent communication, leadership, and stakeholder management skills.
  • Proficient in project management software tools.
  • Willingness to travel internationally and domestically (travel may be required).
  • Able to work in the United States without sponsorship now or in the future.
  • Overtime willingness.
  • PMI PMP or PgMP certification a plus.
Responsibilities
  • Lead project teams to achieve Operational Readiness objectives.
  • Manage readiness-to-operations lifecycle for 1–3 client engagements simultaneously.
  • Drive on-time, on-scope delivery of readiness programs.
  • Serve as the primary consultant for Operational Readiness campaigns integrating with Quality, Process, and Workforce streams.
  • Apply operations excellence principles to pre-Day One activities (e.g., visual management, accountability, problem-solving).
  • Act as a trusted advisor to executive stakeholders (VPs, Site Heads, etc.).
  • Guide decision-making with a risk-based, speed-to-value mindset.
  • Lead and coach cross-functional teams including commissioning, qualification, and validation (CQV), Quality, and external contractors.
  • Cultivate a culture of feedback and growth.
  • Contribute to CAI's brand via white papers, conference presentations, and client tools.
Desired Qualifications
  • PMI PMP or PgMP certification a plus.
  • Black Belt or equivalent certification preferred.
  • Experience with Lean, Six Sigma, or total productive maintenance methodologies.

CAI Technical Consulting Malaysia SDN (cagents.com) delivers operational readiness consulting for pharmaceutical, biotechnology, and healthcare clients to prepare for full-scale production. It works by conducting operational readiness assessments and then providing tailored implementation plans that cover project planning, production operations, asset management, reliability, and sustainability, plus specialized services like Digital Pathology Validation for Leica Biosystems. The firm differentiates itself through active industry collaboration, ongoing professional development, and a global, hands-on approach that pairs quick assessments with practical, cost-effective solutions. Its goal is to help clients achieve operational excellence and successful scale-up by delivering ready-to-deploy strategies and compliant processes.

Company Size

501-1,000

Company Stage

Pre-seed

Total Funding

$3.4M

Headquarters

Indianapolis, Indiana

Founded

1996

Simplify Jobs

Simplify's Take

What believers are saying

  • JLL Partners investment expands CAI globally across four continents for 700 professionals.
  • Fedegari partnership integrates turnkey sterilization, cutting biotech lifecycle costs.
  • CAI's CQV services marked 30 years in 2026, accelerating facility compliance worldwide.

What critics are saying

  • Oracle Life Sciences automates CQV with cloud platforms, eroding CAI's share in 12 months.
  • Fedegari sells sterilization systems directly, capturing pharma clients in 18 months.
  • JLL-mandated expansion dilutes CAI expertise, causing CQV failures in 24 months.

What makes CAI unique

  • CAI specializes in commissioning, qualification, and validation for life sciences facilities.
  • CAI delivers operational readiness assessments for biotech and pharma full-scale production.
  • CAI pioneered neurodiversity hiring in enterprise consulting services.

Help us improve and share your feedback! Did you find this helpful?

Benefits

100% Employee Owned

24 Days PTO/5 Sick days per year + Additional Holidays depending on Country

Medical / Dental / Vision (In accordance with each countries’ applicable regulations)

Professional Development (Approximately $5,000 paid career-related, continuing education)

ESOP/401k – 15% Company Contribution

Company Paid Long-Term Disability

Company Paid Life Insurance

Company Paid Parental Leave (In accordance with each countries’ applicable regulations)

Other Benefits Depending on Country