Process Engineer Consultant

Piper Companies is seeking a Process Engineer Consultant role to join a growing leader in the pharmaceutical/biotechnology space for a contract, onsite position located in Holly Springs, NC. The Process Engineer Consultant will lead engineering support for upstream biomanufacturing operations, coordinating equipment readiness, troubleshooting process issues, and interfacing with cross-functional teams to ensure successful startup and execution of GMP production runs.

Responsibilities of the Process Engineer Consultant include:

• Support upstream manufacturing operations from vial thaw through harvest, including troubleshooting and coordination during PQ and water runs.
• Lead cross-functional coordination for equipment modifications, preventive maintenance, and vendor alignment to ensure readiness for production.
• Act as the primary liaison for issues requiring more than 24 hours to resolve, interfacing with maintenance, CQV, and quality teams.
• Assist in managing parts inventory and procurement for maintenance activities, ensuring timely availability of critical components.
• Provide on-the-floor engineering support during initial GMP runs, contributing to process optimization and procedural development.

Qualifications for the Process Engineer Consultant include:

• Bachelor's degree in Engineering (Chemical Engineering preferred) with 5-10 years of relevant experience in upstream biomanufacturing.
• Hands-on experience with bioreactor operations, including startup and support of live manufacturing runs.
• Proven ability to work independently, manage shifting priorities, and thrive in a dynamic, fast-paced environment.
• Strong interpersonal skills with a track record of integrating well into teams and driving results without constant oversight.
• Experience with large-scale systems (e.g., 20,000L bioreactors, 13,000L media/buffer tanks, depth filtration, chromatography columns) is highly desirable.

Compensation for the Process Engineer Consultant:

• Salary Range: $166,000-$176,000/year
• Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 8/12. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: upstream manufacturing, bioreactor operations, GMP manufacturing, process engineering, chemical engineering, biotech startup, equipment qualification, CQV, preventive maintenance, manufacturing support, cell culture, vial thaw, harvest operations, media prep, buffer prep, depth filtration, chromatography columns, troubleshooting, PQ testing, engineering project coordination, large-scale bioprocessing, 20,000L bioreactor, biotech process development, equipment modification, cross-functional collaboration, independent engineering, senior process engineer, biopharmaceutical, manufacturing run support, equipment readiness, technical operations, process validation, sterility hold, microbial mixing, engineering resource, on-the-floor support

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