A Process Engineer is needed for a Swiss multinational manufacturing company for the pharmaceutical, biotechnology and nutrition sectors, in the Vacaville, CA area. This role is focused on the maintenance, troubleshooting, and reliability of PAT instruments (like Cedex analyzers) to ensure precise monitoring of mammalian cell culture processes within a GMP pharmaceutical manufacturing environment.
location: Vacaville, California
job type: Contract
salary: $21.87 - 36.46 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Provide hands-on technical support, maintenance, and troubleshooting for Process Analytical Technology (PAT) systems in a GMP mammalian cell culture facility.
- Ensure the reliability and readiness of analytical instruments such as cell counters and metabolite analyzers (Cedex Bio, HiRes, and Cobas).
- Collaborate with manufacturing, instrumentation, and engineering teams to assess system issues and perform equipment health checks.
- Execute planned equipment changes, minor upgrades, and configuration updates under the direction of the System Owner.
- Investigate unplanned equipment events and contribute to root cause assessments using structured problem-solving tools.
- Monitor equipment health and implement reliability improvements to maximize system uptime.
- Review and interpret instrument data to identify trends, abnormalities, and potential performance issues.
- Maintain strict adherence to data integrity principles and manage data within systems like Smartline Data Cockpit.
- Document work activities, update technical summaries, and ensure all processes meet regulatory cGMP standards.
- Working knowledge of current Good Manufacturing Practices (cGMPs) as applied to biopharmaceutical manufacturing or similar regulated industries.
- General understanding of biotech analytical methods and laboratory practices.
- Experience troubleshooting analytical instruments and interpreting equipment performance data.
- Flexibility in problem solving and work hours to meet business objectives.
- Familiarity with data management systems; experience with Smartline Data Cockpit is highly desirable.
- strong interpersonal and communication skills; able to work effectively with operators, engineers, scientists, and external vendors.
- Ability to work independently and manage assigned tasks with limited supervision.
- Demonstrated ability to evaluate technical situations, propose solutions, and execute corrective actions.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
