Validation & IT Engineer — CSV/CSA in GxP (Hybrid)

Quality Eng; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Quality Engineering is expanding its US operations and seeks a professional with validation, IT, and regulated environment experience to support pharma and life sciences projects.

You will work directly with client teams, contributing to computerized system validation, qualification, and IT compliance in GxP environments. Location is United States; on-site or hybrid depending on project.

Qualifications

• Bachelor’s degree in a related field.
• Experience in pharmaceutical/biotech/medical device or other regulated industries.
• Experience in Validation, Qualification, CSV, CSA, IT Quality, or related activities.
• Experience working in GxP environments.
• Professional English proficiency to communicate with clients and international teams.

Responsibilities

• Execute or support validation, qualification, CSV, and CSA activities.
• Prepare and review validation documentation, protocols, reports, and other technical deliverables.
• Support IT systems used in GxP environments.
• Participate in risk assessments, deviations, CAPA, and change control activities.
• Collaborate with IT, Quality, Engineering, Validation, and Operations teams.
• Ensure compliance with procedures, quality standards, and regulatory requirements.

Skills

Communication skills

English proficiency

Independent and collaborative work

Client & cross-team interaction

Risk assessment and CAPA understanding

Education

Bachelor’s degree in Engineering, Computer Science, Pharmacy, Chemistry, Life Sciences, or related field

Tools

eTims

SAP

MES

LIMS

TrackWise

Job description

Quality Engineering is expanding its US operations and seeks a professional with validation, IT, and regulated environment experience to support pharma and life sciences projects.

You will work directly with client teams, contributing to computerized system validation, qualification, and IT compliance in GxP environments. Location is United States; on-site or hybrid depending on project.