Senior Quality Engineer

Pharmeng Technology - Marion, NC

Full-time - Mid Level

Marion, NC

Professional, Scientific, and Technical Services

About the position

The Senior Quality Engineer plays a crucial role in supporting the manufacturing plant by focusing on process optimization, risk management, validation, defect prevention, and project management. This position ensures compliance with GMP/QSR standards and provides technical expertise across quality and manufacturing operations, while also mentoring junior engineers. The role encompasses traditional quality engineering tasks alongside project management responsibilities, including overseeing the validation process from design to ongoing verification.

Responsibilities

• Lead or assist in implementing new machines/processes and improving existing methods, including qualification requirements and risk analysis.
• Support manufacturing through process improvements and conduct process/financial analysis using ROI and quality tools.
• Manage small projects involving cost, implementation, and validation.
• Provide statistical support to Quality and Production teams.
• Evaluate sampling, testing, and qualification plans based on current quality standards.
• Oversee testing required for protocols and in-process risk assessments.
• Compose protocols, reports, studies, and general information documents for management use.
• Lead validation efforts for new equipment and modifications to existing equipment.
• Assist in assessing customer complaints and risk management.
• Evaluate supplier product and process changes.
• Ensure compliance with corporate standards, SOPs, GMP/QSR, and ISO regulations.
• Lead or support CAPA investigations using DMAIC methodology.
• Maintain technical writing standards, especially for CAPA/Complaint processes.
• Demonstrate knowledge of international standards relevant to the role.

Requirements

• Minimum of 6 years in a regulated manufacturing environment.
• Bachelor's degree in Engineering preferred; degrees in Engineering Technology, Biology, Microbiology, or Chemistry may be acceptable based on experience.
• Strong technical writing and investigation skills required.
• Proficient in Microsoft Word, Excel, and Outlook, with experience in enterprise software (e.g., JDE, BPLM, POMs, Maximo).
• Familiarity with MINITAB preferred.