MSAT Engineer

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.

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.

Requirements

• 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.

Qualifications

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

Skills

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

Pay

$60.00 - $72.79 per hour

Schedule

9 to 5

Benefits

• Medical, prescription, dental, and vision insurance
• AD&D and life insurance
• Short-term disability
• 401K plan

Location: Sanford, North Carolina
Job type: Contract
Education: Masters