Pharma Validation Engineer (GMP/CSV, Onsite)

Piper Companies; Clayton (NC); Sur place; USD 98 000 - 112 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Sick leave

401K

Résumé du poste

Piper Companies seeks a Validation Engineer for a long-term onsite contract in Clayton, NC. The role spans manufacturing, facilities, laboratory, automation, and quality systems, ensuring GMP and FDA compliance.

Candidates should bring 5+ years of pharma validation, IQ/OQ/PQ experience, and a Bachelor’s degree in a related field. Compensation ranges $71-$81/hr with comprehensive benefits.

Qualifications

• 5+ years of validation experience in pharma/manufacturing.
• Experience with IQ/OQ/PQ and CSV documentation.
• Bachelor's degree in Engineering, Life Sciences, or related field.

Responsabilités

• Develop, revise, and maintain validation lifecycle documentation including validation plans, specifications, risk assessments, traceability matrices, reports, and change control records.
• Author and execute qualification and validation activities such as IQ, OQ, PQ, design reviews, commissioning support, and process validation for manufacturing and facility-based projects.
• Partner with project managers, engineering teams, quality personnel, and vendors to support equipment upgrades, facility modifications, automation initiatives, and technology modernization efforts.
• Investigate deviations, assess validation impacts, document corrective actions, and support change management activities throughout project execution.
• Ensure all validation deliverables meet GMP requirements and align with FDA regulations, GAMP 5 principles, Annex 15 guidance, and internal quality procedures.

Connaissances

Validation

GMP

Documentation

Regulatory

CSV

Engineering

Formation

Bachelor's degree

Outils

SCADA

PLCs

PAS-X

LMES

Veeva

HP ALM

Description du poste

Piper Companies seeks a Validation Engineer for a long-term onsite contract in Clayton, NC. The role spans manufacturing, facilities, laboratory, automation, and quality systems, ensuring GMP and FDA compliance.

Candidates should bring 5+ years of pharma validation, IQ/OQ/PQ experience, and a Bachelor’s degree in a related field. Compensation ranges $71-$81/hr with comprehensive benefits.