Senior Validation Engineer: GMP Automation Lead (Onsite)

Piper Companies; Clayton (NC); On-site; USD 102,000 - 116,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Sick leave

401K

Job summary

Piper Companies is seeking a Senior Validation Engineer to join a rapidly growing biopharma manufacturing organization on an onsite contract in Clayton, NC. The role leads validation for automated manufacturing systems, equipment, and processes within a GMP environment.

The ideal candidate has a strong background in FDA regulations, 21 CFR Part 11, and CSV, with 7+ years in validated settings. You will drive IV/OV/PV activities, change controls, and cross-functional collaboration to keep

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related field.
• 7+ years of validation experience in regulated manufacturing (pharma/biotech/medical devices).
• Strong knowledge of GMP, FDA regulations, 21 CFR Part 11, GAMP 5, ICH guidelines.
• Experience with automated manufacturing equipment validation and change control.
• Proven leadership to manage multiple initiatives and cross-functional teams.

Responsibilities

• Lead IV, OV, and PV protocol development, execution, analysis, and reporting.
• Manage validation change controls and document reviews to meet standards.
• Author validation plans and supporting quality records.
• Investigate deviations with root cause analysis.
• Coordinate FAT, SAT, commissioning, and startup activities with stakeholders.

Skills

GMP knowledge

Project leadership

Root cause investigation

Education

Bachelor's degree in Engineering/CS

Job description

Piper Companies is seeking a Senior Validation Engineer to join a rapidly growing biopharma manufacturing organization on an onsite contract in Clayton, NC. The role leads validation for automated manufacturing systems, equipment, and processes within a GMP environment.

The ideal candidate has a strong background in FDA regulations, 21 CFR Part 11, and CSV, with 7+ years in validated settings. You will drive IV/OV/PV activities, change controls, and cross-functional collaboration to keep