Pharmaceutical Project Manager
San Francisco, California / Pacific SW / Full Time
CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries.
CAI are seeking motivated Project Managers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off.
On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.
To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to.
The Project Manager work with project teams at client sites to inspect, test, and troubleshoot bio-pharma manufacturing, packaging, and utility systems and equipment. This person is responsible for identifying and coordinating activities for commissioning and qualification and creating engineering and qualification protocols and reports. They will also manage the resources (people and budget) for same. The Project Manager will interact with client (Bio-pharma companies) personnel and the Regional Manager. The Project Manager will execute the work as well as oversee it. Aseptic manufacturing experience is highly desired.
BS in a science or engineering field or equivalent experience
5-7+ years’ experience commissioning and qualifying bio-pharmaceutical facilities, systems, and equipment, with project management experience highly preferred.
Experience with developing user requirements, design specifications, process/product risk assessments, validation requirements, development of testing protocols and test plans, and overall experience with the validation life-cycle is required.
Experience with CIP/SIP, and aseptic manufacturing is desired
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.
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