End-to-End Validation Engineer — GMP/CSV & Equipment Expert

Pinnaql, Inc.; Greenville (NC); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Validation Engineer for future opportunities in onsite or hybrid settings. The role covers URS development, FAT/SAT execution, and CSV, with hands-on experience in system integration from design through startup and qualification.

Responsibilities include leading full validation cycles, working with GMP/ISO standards, and managing suppliers on capital projects while delivering compliant engineering documentation.

Qualifications

• Validation lifecycle experience including URS, FAT, SAT, and CSV.
• Lead full project implementations from design to qualification.
• GMP, ISO, Lean, and FDA-regulated environments familiarity.
• Ability to work independently and manage multiple priorities.
• Strong documentation and communication skills.

Responsibilities

• Develop User Requirement Specifications (URS).
• Lead FAT, SAT, CSV and equipment integration activities.
• Drive process design for new equipment to meet requirements.
• Execute commissioning and qualification for new and existing equipment.
• Provide technical oversight to ensure safety, regulatory and operational standards.
• Manage suppliers and external vendors on capital projects.
• Collaborate with Procurement and Legal on vendor contracts.
• Create and maintain engineering documentation (URS, assembly instructions, bill of process).

Skills

Validation lifecycle

CSV

FAT/SAT

Vendor management

GMP compliance

Regulatory knowledge

Education

Bachelor's degree in Engineering or Science

Job description

Validation & Engineering Group, Inc. is seeking a Validation Engineer for future opportunities in onsite or hybrid settings. The role covers URS development, FAT/SAT execution, and CSV, with hands-on experience in system integration from design through startup and qualification.

Responsibilities include leading full validation cycles, working with GMP/ISO standards, and managing suppliers on capital projects while delivering compliant engineering documentation.