The Process Engineer IV provides expert technical support to biologics downstream manufacturing, ensuring robust, compliant, and optimized processes. This role drives performance through data analysis, problem-solving, and cross-functional collaboration in a GMP environment.
One - Year Contract
100% on-site in Framingham, MA
location: Framingham, Massachusetts
job type: Contract
salary: $85 - 88 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Deliver technical expertise and support for downstream biologics manufacturing operations, focusing on troubleshooting, deviation investigations, change assessments, and continuous process improvement in a GMP-compliant environment.
- Collaborate cross-functionally with departments like Manufacturing, Quality, and Engineering to ensure process robustness, drive operational excellence, and support lifecycle management activities.
- Utilize data analytics and digital tools for process monitoring (CPV), root cause analysis, and performance optimization, while contributing to regulatory documentation and tech transfer efforts.
qualifications:
Required:
- A degree in Chemical or Biochemical Engineering related engineering degree.
- 3+ years of experience in biologics downstream manufacturing, including filtration, UF/DF, and chromatography.
- 3+ years of experience with GMP regulations, deviations, and CAPA management.
- Strong data analysis skills and familiarity with systems like MES, LIMS, and Process Data Historians.
skills: Chromatography, Laboratory Information Management Systems (LIMS), GMP (Good Manufacturing Practice), Process Engineering
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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
