Computer System Validation Engineer California
1/29/2016 8:02 AM

Position Summary: The incumbent will be a part of the Validation Department and will perform and/or direct computer system validation projects in compliance with cGMP, 21 CFR Part 11 and Annex 11. Validation projects may include control or computer systems for buildings, equipment, cleaning, process, Aseptic processing, re-validation, and computer systems (i.e. hardware and software). Essen  ...View Job
Manager, Accounting and Compliance California
1/28/2016 3:43 PM

Position Summary: The Manager of Accounting & Compliance is responsible for providing SOX compliance expertise and taking an active role within accounting operations. This individual will frequently interact with accounting staff, IT, legal, and other stakeholders across the organization as well as external SOX consultants and external auditors. This role requires critical thinking skills, effe  ...View Job
Manufacturing Associate II-Purification California
1/6/2016 2:34 PM

You will be a part of the manufacturing organization and provide hands-on execution of tasks related to the cGMP manufacture of biopharmaceuticals working in bacterial fermentation, purification and/or fill-finish. Essential Functions: • Operate in clean room environment. • Assist or perform routine procedures following written instructions (SOPs, batch records, solution documents, protocol  ...View Job
Director, Regulatory Affairs California
1/6/2016 2:34 PM

Position Summary: This position leads the execution, maintenance and monitoring of Regulatory submissions in compliance with approved procedures. This position recommends regulatory strategy and manages global regulatory submissions for development programs. Essential Functions: • Develops, recommends and implements strategies for earliest possible approvals of phase 1 through phase 4 applica  ...View Job
Controls Engineer III California
1/6/2016 2:32 PM

The Controls Engineer provides technical engineering services for manufacturing, building and utility equipment to support operations, validation and capital projects. This position is responsible for plant automation, process control, data management, system life-cycle documentation and overseeing Process Controls support of manufacturing operations for an operational cGMP production facility.   ...View Job