Jobs In Berkeley, California

Associate Director Quality Assurance Site Compliance and Learning

Your tasks and responsibilities The primary responsibilities of this role, Associate Director Quality Assurance Site Compliance and Learning, are to: Accountable for the internal audit/self-assessment program; Ensure that audits are performed per developed schedule; Review findings and makes recommendations for remediation; Ensure timely responses and closure of all action items / commitments; Determine the ability […]

Site Electrical Engineer

Your tasks and responsibilities The primary responsibilities of this role, Site Electrical Engineer, are to: Manage the maintenance activities related to inspection, repairs, and larger/complex turn-around of electrical assets including site generators UPS systems and electrical panel ; initiates, monitors, and tracks work orders; Plan, execute, and monitor multiple basic budget/and multiple larger investments; participate […]

Senior Validation Specialist

Your tasks and responsibilities The primary responsibilities of this role, Senior Validation Specialist, are to: Lead creation and execution of validation deliverables (protocols, tests, IQ/OQ/PQ, etc); Review, execute and approve validation documents; Ensure validation documentation is in compliance with Site and Corporate policies and procedures; Ensure validation follows a lifecycle Approach from URS development through […]

Manager Cell Culture Technology Center Production

Your tasks and responsibilities The primary responsibilities of this role, Manager Cell Culture Technology Center Production, are to: Project Support: Provide technical expertise as an SME to the project team; Execute the project to plan; Closely work with all functional areas to ensure timelines are met safely and compliantly; Challenge assumptions appropriately; Review and Approve […]

Principal Engineer IT Network

Your tasks and responsibilities The primary responsibilities of this role, PCT IT Network Principal Engineer, are to: Perform routine GXP activities per site procedures for periodic reviews, user access to ensure that production IT infrastructure meets current GXP requirements; Implementing technical solutions and technical good practices that are aligned with global best practices and standards […]

Associate Director Regulatory Affairs CMC Biotech

Your tasks and responsibilities The primary responsibilities of this role, Associate Director Regulatory Affairs CMC Biotech, are to: Represent Regulatory Affairs in various cross-functional teams, including CMC development teams, product supply teams, Global regulatory teams; Independently form and implement the regulatory strategy for all “major” and emerging markets, with regard to Chemistry Manufacturing and Controls […]

Director Cell Culture Technology Center

Your tasks and responsibilities At Bayer, we are expanding our biologics manufacturing capabilities. A key component of this is to establish the “Cell Culture Technology Center” at our site in Berkeley, CA. The CCTC, which is under construction, will be a state-of-the-art biomanufacturing facility based on disposable technology and will be ready to manufacture biologics […]

Associate Director Cell Culture Technology Center Plant Engineering

Your tasks and responsibilities At Bayer, we are expanding our biologics manufacturing capabilities. A key component of this is to establish the “Cell Culture Technology Center” at our site in Berkeley, CA. The CCTC, which is under construction, will be a state-of-the-art biomanufacturing facility based on disposable technology and will be ready to manufacture biologics […]

Senior Specialist Validation

Your tasks and responsibilities The primary responsibilities of this role, Senior Specialist Validation, are to: Provide QA oversight for validation lifecycle requirements of Quality Control Laboratories with minimum supervision; Review and approve QC method validation documents, which may include development and periodic review to demonstrate ongoing maintenance of validation status; Who you are Documents may […]

Occupational Health, Safety and Environmental Summer Intern

Your tasks and responsibilities The primary responsibilities of this role, Occupational Health, Safety and Environmental Summer Intern, are to: Survey the facility for confined spaces, conduct an assessment of the permit-entry requirements for each in accordance with California/OSHA regulation, and update the facility”s existing confined space inventory; Audit the site”s existing Walking and Working Surfaces […]