Senior Validation Engineer Onsite CSV/CQV Lead

incog; Fishers (IN); On-site; USD 120,000 - 165,000; Full time

Job summary

INCOG BioPharma in Fishers, IN is seeking a Principal Validation Engineer to lead validation for sterile manufacturing systems, serialization, ERP/QMS/CMMS/MES, and related automation. You will partner with internal clients on projects, serve as SME during audits, mentor other validation engineers, and develop SOPs and templates to raise standards.

This onsite role requires a STEM degree, 10+ years in validation, 4+ years GMP, and readiness to adapt to a fast-changing manufacturing environment.

Qualifications

• Bachelor’s degree or higher in a STEM discipline
• 10+ years of experience in Validation or related discipline
• 4+ years GMP experience
• Physically capable of working onsite

Responsibilities

• Own validation lifecycle planning for projects such as laboratory instruments and systems, serialization, and computerized systems (ERP, QMS, CMMS, MES).
• Serve as the main point of contact and technical lead for client validation support and guidance.
• Provide validation expertise and oversight for capital expansion projects/build outs.
• Develop SOPs, WIs, and guidelines for validation policies, standards, procedures, and templates.
• Mentor and train validation engineers on validation philosophy, strategy, and execution.
• Represent validation during client audits and regulatory inspections as a SME.

Skills

Validation lifecycle

Technical lead

Risk-based CQV

Mentoring

Regulatory audits

Education

STEM degree

Tools

ERP

QMS

CMMS

MES

Job description

INCOG BioPharma in Fishers, IN is seeking a Principal Validation Engineer to lead validation for sterile manufacturing systems, serialization, ERP/QMS/CMMS/MES, and related automation. You will partner with internal clients on projects, serve as SME during audits, mentor other validation engineers, and develop SOPs and templates to raise standards.

This onsite role requires a STEM degree, 10+ years in validation, 4+ years GMP, and readiness to adapt to a fast-changing manufacturing environment.