Process Engineer II - Visual Inspection & GMP Tech Transfer

Merck & Co.; Holly Springs (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Merck & Co. is seeking a Process Engineer 2 to support DPFG in Visual Inspection, delivering engineering guidance for capital projects, technology transfer, and manufacturing operations under CGMP.

The role emphasizes efficient, scalable processes and reliable equipment, with hands-on experience in camera- and vision-based inspection systems. Responsibilities include coordinating with EPCM providers, reviewing P&IDs, supporting FAT/CQV, leading deviations and CAPAs, and training site personnel.

Qualifications

• Bachelor’s degree in Chemical or Biotechnology Engineering, or related field with 2 years engineering experience; or Master’s with no prior experience.
• Experience in Life Science or other regulated industry.
• Experience with Engineering drawings and using Quality Systems (deviation management, change control, CAPA, document management system).
• Prior experience in cGMP environment or other highly regulated industry (preferred).

Responsibilities

• Serve as point of contact to EPCM provider and ensure on-time delivery.
• Review P&IDs and provide direction to detailed design activities.
• Support FAT, CQV, and startup activities.
• Provide on-floor manufacturing support and RCA/CAPA investigations.
• Lead deviations, change controls and CAPA closures.
• Collaborate with Quality, Manufacturing, Process Science, Maintenance, and Automation.

Skills

Engineering experience

Regulatory knowledge

Automation drawing interpretation

Education

Bachelor’s in Chemical/Biotechnology Engineering

Master’s in Chemical/Biotechnology Engineering (no experience)

Tools

Engineering drawings

Quality Systems (deviation management, change control, CAPA, document mgmt)

Job description

Merck & Co. is seeking a Process Engineer 2 to support DPFG in Visual Inspection, delivering engineering guidance for capital projects, technology transfer, and manufacturing operations under CGMP.

The role emphasizes efficient, scalable processes and reliable equipment, with hands-on experience in camera- and vision-based inspection systems. Responsibilities include coordinating with EPCM providers, reviewing P&IDs, supporting FAT/CQV, leading deviations and CAPAs, and training site personnel.