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.
- 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 (minimum of 2 years of experience in the following):
- Commissioning, qualification, validation, or operation and maintenance across 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;
- Working knowledge of 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;
- Training and knowledge of the standard validation lifecycle approach and related documentation, including requirements definition, design review, risk assessments, commissioning, installation and operational qualification, performance qualification, , change control, requalification, and decommissioning;
- Authoring and/or understanding of mechanical and process system user requirements;
- Understanding of mechanical and process system piping and instrumentation diagrams, system logic diagrams, sequence of operations, design engineering calculations, mechanical and process equipment data sheets, and/or instrumentation and controls data sheets;
- Authoring and executing test plans to challenge mechanical and process operation and performance;
- Providing technical support and technical expertise to project teams to facilitate resolution of testing discrepancies and issues, either from direct experience or from available source materials.
- 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.