Operations Performance Specialist

Raleigh, North Carolina  /  South Atlantic  /  Full Time

About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI Operations Performance Specialists will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
Position Description:
Your responsibilities as Operations Performance Specialist will include:
Delivering solutions such as process maps and workflows, procedures, training programs and content, and staffing plans to support the operational readiness of new or expanding biotech and pharmaceutical manufacturing sites.
Support operational improvement / excellence in existing manufacturing sites through GMP floor observation and/or coaching, process and performance improvement development and execution, and performance-based deviation investigation and risk control.
Active in creating industry-changing approaches that help guide clients and the broader industry toward higher performance.
Participating in professional societies to support industry improvement and expand CAI’s store of knowledge.
Position Requirements:
BS in a science or engineering field or equivalent years’ experience
2+ years of experience in GMP Operations as Manufacturing Operator, Group Lead, Supervisor, and/or Manager
Experience in drug substance and/or drug product manufacturing including such systems/processes as Aseptic Filling lines, Lyophilizes, Depyrogenation, Vial Washer, Isolators, Bioreactors, AKTA skids, Fill skids, BSCs
Demonstrated experience in developing and/or continuous improvement in GMP on-floor operations, SOPs, Batch Records, and related processes / documentation
Demonstrated understanding of Good Documentation Practices
Lean practice education and experience is a plus
Superior oral and written communication skills in English, including communication with site supervision and management
Other Requirements:
Excellent oral and written communication skills in English 
Able to travel domestically and internationally if required 
Able to work (paid) overtime 
Able to work in the US without sponsorship now or any time or in the future
Must have been vaccinated or willing to be vaccinated for COVID-19 prior to starting employment



(Varies by Country, Below is a General Overview)

  • 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