Validation Engineer II – Process Equipment

About Us

Total Validation Services (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!

Summary

Validation Engineer II is a full-time specialty, technical, professionalposition. A Validation Engineer II isresponsible for reviewing engineering design documentation, developing testingmethodologies, authoring commissioning, qualification, and validation testingprotocols, performing (executing) field testing, and authoring final reports tocompleted testing.

A Process Equipment Validation Engineer is responsible for understandingthe design and operation of mechanical systems and process equipment,instrumentation / metrology / measurements, heat transfer thermodynamics, fluidflow dynamics, programmable system control, engineering drawings, conceptualand practical implementation of high purity systems, and pharmaceutical and/orbiotechnology manufacturing processes.

Position BasicQualifications:

AppropriateEducation:

• Bachelorof Science degree (or equivalent conferred degree) in Mechanical engineering, Chemicalengineering, Biotechnology/Pharmaceutical Engineering, or equivalent programand 5 to 10 years of experience in process equipment systems testing position,preferably in pharmaceutical, biotechnology, or related engineeringindustry/field; or
• Master ofScience degree (or equivalent conferred degree) in Mechanical engineering,Chemical engineering, Biotechnology/Pharmaceutical Engineering, or equivalentprogram and 1 to 5 years of experience in above described system testing.
• Authorization/ eligibility to work in the United States.

PositionRequirements

• Able toauthor and/or understand mechanical and process system design requirements.
• Able tounderstand mechanical and process system piping and instrumentation diagrams.
• Able tounderstand mechanical and process system logic diagrams and sequence ofoperations.
• Able tounderstand and review system design engineering calculations.
• Able toauthor and execute test plans to challenge mechanical and process operation andperformance.
• Able toauthor and/or review mechanical and process equipment data sheets.
• Able toauthor and/or review instrumentation and controls data sheets.
• Experiencewith programming and programming logic (e.g., Visual Basic, SQL, C, etc.) aplus.

OperationalResponsibilities

• Supportsidentification of new opportunities at assigned project /client site(s)
• Supportsdevelopment of scope documents, estimates, and proposals for prospectiveprojects.
• Participatesin industry functions
• Supportsspecific activities as assigned for development of company infrastructure.
• SupportsMarketing and Business Development activities as required.
• Participatesin 360 review and employee development processes for continuous improvement.

?Project Responsibilities

• Responsiblefor functioning and operating in a regulated pharmaceutical / biotechnologymanufacturing environment, subject to compliance with current GoodManufacturing Practices (cGMPs).

• Responsiblefor preparing, executing, and/or reviewing commissioning, qualification, and validationdeliverables as assigned by the Project Manager, or assigned supervisor. Such items may include (but are not limitedto) the following: user requirements specifications, user functionalrequirement specifications , impact assessments, risk assessments, start-up/shake-downplans and procedures, commissioning protocols and test plans, qualification protocolsand test plans (e.g., IQ, OQ, PQ), final report packages, traceabilitymatrices, and standard operating procedures. May also assist in the development and review of other documentation deliverablesrequired for completion of a project.
• Responsiblefor providing technical support and technical expertise to project team tofacilitate resolution of system and quality issues, either from directexperience or from available source materials.
• Responsiblefor performing commissioning testing (e.g., factory acceptance testing, siteacceptance testing, startup/shakedown testing) as identified and assigned bythe Project Manager, or assigned supervisor. The work may include thepreparation or review of the acceptance testing protocol
• Responsiblefor review of the vendor or contractor documentation as required by the ProjectManager, or assigned supervisor.
• Interactsdirectly with client on an as needed basis regarding system/process specificactivities and basic project related activities.
• Plans,organizes, and tracks assigned tasks to ensure that the schedule commitmentsare kept.
• Responsiblefor submitting any required report on progress of assigned tasks (weekly)
• Other Proficiencies
• Proficiencyin commissioning, qualification, and validation of at least one of thefollowing areas: cell culture, column chromatography, tangential flowfiltration, solution prep, process filtration, powder or liquid filling,lyophilization, granulation, powder mixing.
• Expectedsoftware proficiencies: Microsoft Officeapplications (Outlook, Word, Excel, PowerPoint). Working knowledge andunderstanding of online collaboration tools (e.g., MS Teams, MS SharePoint,OneNote), project management software (e.g., MS Project, Primavera, etc.), anddatabase software (e.g. MS Access, SAP) is a plus.
• Work isaccomplished without considerable direction.
• Works onassignments of diverse and complex scope.
• Interpretsless defined guidelines to make recommendations for process improvements and/orenhancements.
• Involvesinterpreting and analyzing established concepts and trends.
• Exercisesconsiderable judgment for decision-making with complex issues.
• Requiresin-depth analysis to identify and recommend new solutions, which requirecreativity and innovation, for more complex problems.
• Demonstratesthoughtful interactions with a diverse group of individuals, sensitivity tocultural differences in values, beliefs, etc.