Process Engineer

A Process Engineer is needed for a global healthcare leader that discovers, develops and distributes therapeutic solutions focused on patient's needs in the St. Louis, MO area. The role involves providing technical support, process monitoring, and data analysis for commercial mammalian cell culture processes at external manufacturing sites, with responsibilities including troubleshooting, deviation resolution, and collaboration with cross-functional teams to ensure efficient and compliant production.

education: Bachelors

responsibilities:

• Work with a team of scientists and engineers supporting commercial mammalian cell culture processes in the external manufacturing MSAT group.
• Support commercial operations across a network of manufacturing facilities and external partners.
• Provide technical support and routine process monitoring for commercial products manufactured at Contract Manufacturing Organizations (CMOs).
• Conduct person-in-plant observations of manufacturing operations at CMOs and communicate findings to the product team.
• Review manufacturing processes, deviations, and development and production data.
• Review manufacturing batch records, protocols, and control strategies.
• Provide technical support and data analysis for investigations and deviation resolution.
• Recommend changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
• Collaborate with colleagues and external partners in Engineering, Manufacturing, and Quality departments.
• Oversee and report on overall manufacturing progress.

Skills:

• Preferred experience with Good Manufacturing Practices (GMP) and supporting a commercial facility.
• Preferred experience in cell culture and/or downstream purification, including direct lab experience.
• Familiarity with equipment qualification and process validation.
• Knowledge of formal root cause analysis and risk assessment.
• Experience with statistical analysis software and investigative data analysis.
• Demonstrated project leadership skills.
• strong communication and technical writing skills.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Education and Experience:

• Possess a Bachelor's degree in engineering or science with 5 years of experience or
• A Master's degree with 3 years of experience.
• Have experience in biologics development, bioprocess engineering, technology transfer, and/or commercial manufacturing operations.

#LI-MA1

qualifications:

• Experience level: Experienced
• Education: Bachelors

• Professional Engineer
• Validation

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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.