job summary: Ready to play a pivotal role in bringing life-changing therapeutics to market? A leading biopharmaceutical organization is seeking an MSAT Engineer on-site to lead preparation and execution for an upcoming Process Performance Qualification (PPQ) campaign. This is a high-visibility opportunity to drive cross-functional alignment and champion process integrity in a fast-paced cGMP environment.

location: Sanford, North Carolina job type: Contract salary: $60.00 - 72.79 per hour work hours: 9 to 5 education: Masters

responsibilities:

• Author, review, and execute PPQ protocols, supporting study reports, and single-use mixing and kLa studies.
• Facilitate cross-functional reviews across Manufacturing, Quality, Validation, and Regulatory teams.
• Support hands-on execution in GMP suites, including sample aliquoting and real-time campaign data trending.
• Transition process FMEAs and viral safety risk assessments into TrackWise eQMS, updating site risk mitigations based on characterization data.
• Investigate process deviations, conduct root cause analyses, and drive CAPAs to resolution.

qualifications: Required

• PhD in Engineering/Life Sciences, MS with 2+ years of relevant experience, or BS with 4+ years of relevant experience.
• Hands-on experience in biologics cGMP tech transfer and late-stage process performance qualification (PPQ).
• Strong working knowledge of CMC regulatory guidelines, process monitoring, and monoclonal antibody Critical Quality Attributes (CQAs).
• Familiarity with cGMP, ICH, ISPE, and BPE industry guidelines.

Preferred:

• Direct experience with gene therapy, single-use bioreactors, and JMP statistical analysis software.

LI-AH1

skills: Process Engineering, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Technology Transfer, International Council for Harmonization (ICH), Quality Management Systems (QMS)

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.

,

• Author, review, and execute PPQ protocols, supporting study reports, and single-use mixing and kLa studies.
• Facilitate cross-functional reviews across Manufacturing, Quality, Validation, and Regulatory teams.
• Support hands-on execution in GMP suites, including sample aliquoting and real-time campaign data trending.
• Transition process FMEAs and viral safety risk assessments into TrackWise eQMS, updating site risk mitigations based on characterization data.
• Investigate process deviations, conduct root cause analyses, and drive CAPAs to resolution.

Process Engineering, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Technology Transfer, International Council for Harmonization (ICH), Quality Management Systems (QMS)