Overview:
TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological expertise with world-class manufacturing and scientific insight to support the delivery of innovative medicines for a wide range of diseases. Specializing in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, and cell and gene therapy, the company provides comprehensive services across the pharmaceutical, biotech, and life sciences sectors. It supports every stage of drug development, from early research to commercial production, and offers solutions in biologics, small molecules, and specialty ingredients. Committed to quality and innovation, the company serves as a critical partner in advancing therapeutic solutions and streamlining complex manufacturing processes, with a global presence that ensures access to scalable, flexible, and compliant technical expertise.
Job Title: Manufacturing Process Engineer
Location: Vacaville, CA
Duration: 6 months
Job Type: Temporary Position
Work Type: Onsite
Summary
This role provides hands-on technical support for Process Analytical Technology (PAT) systems deployed on the manufacturing floor in a large-scale biopharmaceutical facility. These systems are critical for monitoring mammalian cell culture processes, including parameters such as cell density, viability, and metabolite concentrations. Ensuring system reliability and readiness is essential to maintaining consistent manufacturing performance.
The role supports daily operation, maintenance, troubleshooting, and repair of PAT instruments used in GMP manufacturing. The individual will collaborate closely with the Frontline Upstream (FLUS) System Owner, Manufacturing, and Instrumentation teams to assess system issues, conduct health checks, implement improvements, and support investigations related to unplanned events. This position also supports the deployment of multiple new PAT systems alongside existing instruments and offers valuable hands-on experience with advanced analytical technologies used in mammalian cell culture and purification operations.
Key Accountabilities:
- Perform routine maintenance, calibration checks, and system readiness activities for PAT instruments such as cell counters and metabolic analyzers (e.g., Cedex Bio, Cedex HiRes, Cedex Cobas).
- Support manufacturing operations by responding to system-related issues, troubleshooting instrument performance, and documenting observations.
- Assist in investigating unplanned equipment events using structured problem-solving tools and contribute to root cause analysis.
- Conduct equipment health monitoring and support reliability improvement initiatives to enhance system uptime.
- Execute planned equipment modifications, minor upgrades, and configuration updates under guidance from the PAT System Owner.
- Review and interpret instrument data to identify trends and abnormalities.
- Support adherence to data integrity principles and maintain data consistency within data management systems.
- Collaborate with Manufacturing, FLUS, Automation, QA, and external vendors to ensure optimal system performance.
- Assist with documentation updates, work tracking, and preparation of technical summaries.
- Work independently to complete assigned tasks while providing regular progress updates to stakeholders.
Required Qualifications- B.S., M.S., or Ph.D. in Engineering or a scientific/analytical discipline.
- Prior hands-on experience with analytical systems.
- Experience with cell counters and metabolite analyzers such as Cedex Bio, Cedex HiRes, and Cedex Cobas in GMP manufacturing or QC laboratory settings.
- Experience troubleshooting analytical instruments and interpreting equipment performance data.
- General understanding of biotech analytical methods and laboratory practices.
- Strong verbal and written communication skills, including documentation and reporting.
- Ability to work independently and manage responsibilities with minimal supervision.
- Strong interpersonal skills with the ability to collaborate effectively across cross-functional teams.
- Demonstrated ability to evaluate technical issues and implement corrective actions.
- Familiarity with data management systems; experience with Smartline Data Cockpit is highly desirable.
- Strategic thinking mindset with the ability to translate system requirements into actionable activities.
- Flexibility in problem-solving and work hours to meet business objectives.
- Ability to build strong working relationships with end users and equipment vendors.
- Customer-focused approach with strong partnership-building skills.
- Working knowledge of current Good Manufacturing Practices (cGMPs) in biopharmaceutical or regulated manufacturing environments.
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.
Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.
TekWissen® is an equal opportunity employer supporting workplace diversity.