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.

Requirements include: 

BS in a science or engineering field or equivalent years’ experience

4+ 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

           

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

CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 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.

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.

$87,100 - $94,600 a year

We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

 

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).