VALIDATION & IT ENGINEER

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 operations in the United States and is seeking a professional with experience in Validation, IT, and regulated environments* to support pharmaceutical and life sciences projects.

You will work directly with client teams, contributing to computerized system validation, qualification, and IT compliance in GxP environments.

Location: United States

Work model: On-site or hybrid, depending on the project.

Key Responsibilities

Execute or support validation, qualification, Computerized System Validation (CSV), and Computer Software Assurance (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, as applicable.

Collaborate with IT, Quality, Engineering, Validation, and Operations teams.

Ensure compliance with applicable procedures, quality standards, and regulatory requirements.

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Pharmacy, Chemistry, Life Sciences, or a related field.
• Professional experience in the pharmaceutical, biotechnology, medical device, or another regulated industry.
• 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.
• Strong communication skills and the ability to work independently and collaboratively.
• Valid legal authorization to work in the United States and availability to work in the country.

Preferred Qualifications

• Experience working at pharmaceutical manufacturing sites in the United States.
• Familiarity with platforms such as eTims, SAP, MES, LIMS, and TrackWise.
• Experience with deviations, CAPA, change control, and risk management.
• Experience working with major pharmaceutical companies and international teams.

We value technical accountability, a strong commitment to quality, and clear communication with our clients.

Quality Engineering provides equal employment opportunities to qualified candidates and values diversity across its teams.