Total Validation Services, Inc. (TVS, Inc.), has had almost three decades of experience in providing independent contract validation services to the biotechnology industry. Maintaining a solid track record of success, we have grown and expanded our portfolio to provide a broad range of commissioning, qualification, validation, quality, compliance, and project management services to span all facets of the pharmaceutical, biotechnology, and medical device industries—making us a leader in this space.
We’re looking for people who thrive from figuring out how something works; making sure that it’s performing properly; and who find meaning in having a role that contributes to delivering lifesaving therapies to patients. We, at TVS, Inc., serve large and small clients throughout the Bay Area and are expanding throughout the West Coast. TVS is proud to work alongside our clients to create teams that deliver solutions for projects of all sizes. We value our employees and our collaborative work culture. Almost all of our team members work with other TVS people on-site to operate as a team. We need more smart, proactive and hardworking people to join us!
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 to completed testing.
A Process Equipment Validation Engineer is responsible for understanding the design and operation of mechanical systems and process equipment, instrumentation / metrology / measurements, heat transfer thermodynamics, fluid flow dynamics, programmable system control, engineering drawings, conceptual and practical implementation of high purity systems, and pharmaceutical and/or biotechnology manufacturing processes.
Position Basic Qualifications
· Bachelor of Science degree (or equivalent conferred degree) in Mechanical engineering, Chemical engineering, Biotechnology/Pharmaceutical Engineering, or equivalent program and 5 to 10 years of experience in process equipment systems testing position, preferably in pharmaceutical, biotechnology, or related engineering industry/field; or
· Master of Science degree (or equivalent conferred degree) in Mechanical engineering, Chemical engineering, Biotechnology/Pharmaceutical Engineering, or equivalent program and 1 to 5 years of experience in above described system testing.
· Authorization / eligibility to work in the United States.
· 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.
· Supports identification of new opportunities at assigned project /client site(s)
· Supports development of scope documents, estimates, and proposals for prospective projects.
· Participates in industry functions
· Supports specific activities as assigned for development of company infrastructure.
· Supports Marketing and Business Development activities as required.
· Participates in 360 review and employee development processes for continuous improvement.
· Responsible for functioning and operating in a regulated pharmaceutical / biotechnology manufacturing environment, subject to compliance with current Good Manufacturing Practices(cGMPs).
· 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.
· 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)
· Proficiency in commissioning, qualification, and validation of at least one of the following areas: cell culture, column chromatography, tangential flow filtration, solution prep, process filtration, powder or liquid filling, lyophilization, granulation, powder mixing.
· 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.