Validation Engineer jobs in Berkeley, CA

Validation Engineer II is a full-time specialty, technical, professional position. A Validation Engineer II is responsible for reviewing engineering design documentation, developing testing methodologies, authoring commissioning, qualification, and validation testing protocols, performing (executing) field testing, and authoring final reports for completed testing.

• Position Basic Qualifications:
  • Masters of Science degree in Chemical engineering and 2 years of experience as a Validation Engineer or Automation Engineer
  • Permanent authorization to work in the United States.
• Position Requirements
  • Able to author and/or understand mechanical and process system design requirements.
  • Able to understand mechanical and process system piping and instrumentation diagrams.
  • Able to understand mechanical and process system logic diagrams and sequence of operations.
  • Able to understand and review system design engineering calculations.
  • Able to author and execute test plans to challenge mechanical and process operation and performance.
  • Able to author and/or review mechanical and process equipment data sheets.
  • Able to author and/or review instrumentation and controls data sheets.
  • Experience with programming and programming logic (e.g., Visual Basic, SQL, C, etc.) a plus.
• Project Responsibilities
  • Responsible for functioning and operating in a regulated pharmaceutical / biotechnology manufacturing and laboratory environments, subject to compliance with current Good Manufacturing / Laboratory / Documentation / Engineering Practices (cGxPs), as it relates to development, manufacture, testing, holding, and/or distribution of medicinal products for clinical or commercial use;
  • Responsible for preparing, executing, and/or reviewing commissioning, qualification, and validation deliverables as assigned by the Project Manager, or assigned supervisor. Such items may include (but are not limited to) the following: user requirements specifications, user functional requirement specifications , impact assessments, risk assessments, start-up/shake-down plans and procedures, commissioning protocols and test plans, qualification protocols and test plans (e.g., IQ, OQ, PQ), final report packages, traceability matrices, and standard operating procedures. May also assist in the development and review of other documentation deliverables required for completion of a project (e.g., design review, change control, requalification, decommissioning, etc.).
  • Responsible for providing technical support and technical expertise to project team to facilitate resolution of system and quality issues, either from direct experience or from available source materials.
  • Responsible for performing commissioning testing (e.g., factory acceptance testing, site acceptance testing, startup/shakedown testing) as identified and assigned by the Project Manager or assigned supervisor. The work may include the preparation or review of the acceptance testing protocol
  • Responsible for review of the vendor or contractor documentation as required by the Project Manager or assigned supervisor.
  • Interacts directly with client on an as needed basis regarding system/process specific activities and basic project related activities.
  • Plans, organizes, and tracks assigned tasks to ensure that the schedule commitments are kept.
  • Responsible for submitting any required report on progress of assigned tasks (weekly)
• Other Proficiencies
  • Proficiency in commissioning, qualification, and validation of one or more of the following areas: small molecule process equipment, cell culture process equipment, complex molecule purification equipment, solution prep, process filtration, powder or liquid filling, sterilization, analytical testing, aseptic processing equipment, material handling and storage, facility fit/finish, facility utility systems (high purity water systems, compressed gas systems, HVAC systems), automation systems.
  • Expected software proficiencies: Microsoft Office applications (Outlook, Word, Excel, PowerPoint). Working knowledge and understanding of online collaboration tools (e.g., MS Teams, MS SharePoint, OneNote), project management software (e.g., MS Project, Primavera, etc.), and database software (e.g. MS Access, SAP) is a plus.
  • Work is accomplished without considerable direction.
  • Works on assignments of diverse and complex scope.
  • Interprets less defined guidelines to make recommendations for process improvements and/or enhancements.
  • Involves interpreting and analyzing established concepts and trends.
  • Exercises considerable judgment for decision-making with complex issues.
  • Requires in-depth analysis to identify and recommend new solutions, which require creativity and innovation, for more complex problems.
  • Demonstrates thoughtful interactions with a diverse group of individuals, sensitivity to cultural differences in values, beliefs, etc.

Total Validation Services, Inc. seeks a Validation Engineer II in Moraga, CA. Requires Master’s Degree in Chemical Engineering plus 2 years of experience as Associate Validation Engineer or Automation Engineer. Annual salary is $111,072.00. Send resume & cover letter to: Total Validation Services, Inc. Attn: HR, 1024 Country Club Dr. Ste 100, Moraga, CA 94556. Please reference job #D1. Need permanent authorization to work in the U.S.