Job Details

HTI has an immediate opening for an experienced Quality Engineer with a large pharmaceutical manufacturing company in Greenville, SC. This is a full-time, onsite, direct hire position with a salary range of $70,000 - $80,000 / year (depending on experience and education). Relocation assistance is available. This company offers fantastic benefits and opportunities for growth and advancement.

Requirements:

• Must have a Bachelor's degree in Mechanical Engineering, Chemical Engineering, Chemistry, or a closely related field
• Must have 3+ years of experience in a pharmaceutical or other FDA-regulated manufacturing plant (biotech, food, nutraceutical, etc.)
• Must have 3+ years of quality engineering experience conducting deviation investigations, performing root cause analysis and CAPAs.
• Experience using electronic quality systems (TrackWise strongly preferred).
• Strong technical problem-solving skills.
• Ability to synthesize data and clearly articulate investigation conclusions; strong verbal/written communication skills.
• Strong understanding of cGMP, documentation practices, and regulatory expectations.
• Effective facilitation and communication skills across multiple departments.
• Must be authorized to work in the U.S. without visa sponsorship (now or in the future).

Job Summary:
The Quality Engineer independently leads standard deviation investigations related to manufacturing, packaging, material handling, and laboratory support activities. This role performs structured root cause analysis, develops and implements CAPAs, and ensures that investigation reports are complete, scientifically sound, and compliant. The Quality Engineer acts as a technical resource for operations and supports continuous improvement of investigation and CAPA processes.

Job Duties include:

• Lead full lifecycle of routine and moderately complex deviation investigations.
• Perform thorough assessment of potential product impact, quality risks, and systemic implications.
• Conduct structured root cause analysis and document rationale for conclusions.
• Author clear, complete, and well-supported investigation reports suitable for internal and regulatory review.
• Identify, propose, and implement effective CAPAs tied directly to identified root causes.
• Collaborate with Manufacturing, Packaging, QC, and Facilities to validate findings and ensure implementation feasibility.
• Perform CAPA effectiveness checks and identify opportunities for prevention-based solutions.
• Contribute to trending reports and communicate findings to management.
• Support training and mentoring of junior QE staff or Specialists.
• Participate in inspection readiness activities and present investigations during audits.

INDPRO