Senior Validation Engineer

Junior Validation Engineer – Job AX037-SD A junior level Validation Engineer needed for a permanent placement opportunity in the San Diego, CA area. The Validation Engineer will be responsible for developing client process validations, such as sterile filling, sterilization, and cleaning studies. Additional duties will include knowledge of utility systems qualification. Areas of Responsibility Assist administration activities Oversee and support the execution of IQ, OQ, PQ Participate in the collection and analysis of validation data Review documentation/protocols Assist in the writing of URS/FRS documentation Sustain VMP and CVMP schedules Bachelor’s degree preferred in natural science discipline Familiar with regulatory and GMP requirements for pharmaceutical manufacturing operations PC proficient with Microsoft Office, Google suite, statistical analysis software, and contract management software Qualifications BS degree and 3+ years of relevant industry experience Must have strong quality validation industry experience Thorough knowledge of ISO 14644 Class 7 clean room regulations Advanced knowledge of ISO 13485 regulations. Senior Validation Engineer – Job AX067-SF A senior level Validation Engineer needed for a permanent placement opportunity in the San Francisco Bay Area. The candidate will be part of the Cleaning/Sterilization Validation team, and will independently complete activities related to the items below: Ensuring all aspects of Cleaning and Sterilization Validation adhere to the customer’s global policies, procedures and guidelines, and external regulatory requirements; Generating and executing validation protocols to demonstrate compliance to a standard suitable for review by internal and external auditors; Authoring, Review and/or Oversight of cleaning and sterilization validation-related procedures, protocols and technical reports required; Providing product impact and root cause assessments on cleaning and sterilization related events and anticipated changes; Driving improvements in cleaning and sterilization validation. Areas of Responsibility Primary source for cleaning and sterilization validation systems knowledge, including experience with Validation of steam in place (SIP) sterilization, autoclave sterilization, dry heat sterilization and sterilizing filtration. Responsible for validation-related activities, such as: Develop sterilization re-validation programs, as appropriate; Accountable for compliance of the site sterilization validation program via documentation completion, risk assessments, proactive identification of risks /issues, review of protocols and reports, closure of preventative and corrective actions, and participation in audits and inspections; Participate on investigation teams in the event of adverse sterilization validation trends/failures to identify root cause and corrective/preventative actions. Facilitates in problem solving & risk assessment (FMEA) projects/meetings; Develop meaningful validation metrics/trending to enable continued drive for reliability and efficiency. Qualifications Academic degree in life sciences (biotechnology or related) or comparable level through experience; At least 5 years of validation/ manufacturing experience, in a GMP setting. Preference for experience in biologics manufacturing (cell culture, purification); Strong communicator and ability to build bridges between groups and organizations. Ability to create a team spirit; Knowledge of GMP guidelines and global validation expectations; Customer focused, process oriented and data driven; #J-18808-Ljbffr