Onsite Pharma Validation Engineer - GMP/CSV Expert

Piper Companies; Clayton (NC); On-site; USD 98,000 - 112,000; Full time

Benefits offered by this job

Medical benefits

401K

Sick leave as required by law

Job summary

Piper Companies seeks a Validation Engineer for a long-term onsite contract in Clayton, NC, to support validation work across manufacturing, facilities, lab, automation, and quality systems while maintaining GMP/FDA compliance.

Ideal candidate brings 5+ years in pharma validation, hands-on IQ/OQ/PQ, and experience with SCADA, PLCs, PAS-X, LMES, Veeva, and HP ALM/TIMS in regulated settings.

Qualifications

• 5+ years of validation experience in pharma or regulated manufacturing.
• Hands-on with manufacturing equipment, aseptic processing, packaging, labs, utilities or facilities.
• Knowledge of computerized systems validation and familiar with stated platforms.
• Experience authoring qualification protocols and validation reports.
• Bachelor’s degree in Engineering, Life Sciences, Computer Systems or related field.

Responsibilities

• Develop, revise, and maintain validation lifecycle docs (validation plans, specs, risk assessments, traceability, reports, change control).
• Author and execute IQ, OQ, PQ, design reviews, commissioning support, and process validation.
• Partner with project managers, engineering, QA, and vendors for equipment upgrades and facility mods.
• Investigate deviations, assess validation impact, document corrective actions, support change management.
• Ensure all validation deliverables meet GMP and FDA, GAMP5, Annex 15, and internal procedures.

Skills

Validation experience

GMP knowledge

Regulated manufacturing

Deviation management

Education

Bachelor’s degree in Engineering

Tools

SCADA

PLCs

PAS-X

LMES

Veeva

HP ALM/TIMS

Job description

Piper Companies seeks a Validation Engineer for a long-term onsite contract in Clayton, NC, to support validation work across manufacturing, facilities, lab, automation, and quality systems while maintaining GMP/FDA compliance.

Ideal candidate brings 5+ years in pharma validation, hands-on IQ/OQ/PQ, and experience with SCADA, PLCs, PAS-X, LMES, Veeva, and HP ALM/TIMS in regulated settings.