CSV Validation Specialist – GMP Biopharma Systems

Insight Global; Conshohocken (Montgomery County); On-site; USD 54,773 - 67,047; Full time

Benefits offered by this job

10 Days of PTO

6 Sick Days

Company Holidays

Medical, dental, and vision insurance

401k retirement account access with employer matching

Job summary

Insight Global is looking for a Validation Engineer in Lititz, PA, to support a major biopharmaceutical project focused on computerized lab equipment. As a key player, you will execute validation deliverables, perform system impact assessments, and partner with IT and Quality teams to ensure all systems comply with regulatory standards.

The ideal candidate will have a Bachelor’s degree and significant experience in CSV within a GMP environment. This full-time position offers a competitive hourly compensation ranging from $39.76/hr to $48.67/hr, alongside comprehensive benefits starting on your first day.

Qualifications

• 3–7+ years of experience in a GMP biopharmaceutical, biotech, or pharmaceutical environment.
• Executing Validation Protocols / Authoring Protocols.
• Deep experience in Computer System Validation (CSV) within a regulated biopharmaceutical environment.

Responsibilities

• Work on CSV activities related to the Windows 11 operating system upgrade.
• Perform system impact assessments and risk evaluations.
• Develop and execute validation documentation including validation summary reports.

Skills

CSV experience

System Validation

Regulatory compliance

Education

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

Job description

Insight Global is looking for a Validation Engineer in Lititz, PA, to support a major biopharmaceutical project focused on computerized lab equipment. As a key player, you will execute validation deliverables, perform system impact assessments, and partner with IT and Quality teams to ensure all systems comply with regulatory standards.

The ideal candidate will have a Bachelor’s degree and significant experience in CSV within a GMP environment. This full-time position offers a competitive hourly compensation ranging from $39.76/hr to $48.67/hr, alongside comprehensive benefits starting on your first day.