Senior Validation Engineer - Pharma, cGMP & CAPA Lead

Modis; Swiftwater (Monroe County); On-site; USD 83,000 - 110,000; Full time

Job summary

Modis is seeking a Validation Engineer III for a contract role in Swiftwater, PA. The ideal candidate has solid pharma/biotech QA exposure and hands-on work with regulatory compliance.

The role focuses on cGMP operations, validation activities across formulation, filling, lyophilization, and investigations, and management of CAPAs and change controls. A Bachelor's degree and 3–5 years of relevant experience are required.

Qualifications

• Bachelor's degree required with 3–5 years of relevant experience in pharmaceutical manufacturing, Quality Systems, Continuous Improvement, or a related regulated environment.
• Strong knowledge of cGMP requirements and pharmaceutical manufacturing operations.
• Experience with formulation, filling, lyophilization, and/or inspection processes.
• Experience managing CAPAs, Change Controls, quality investigations, and root cause analysis.

Responsibilities

• Bachelor's degree required with minimum 3-5 years of relevant experience in pharmaceutical manufacturing, Quality Systems, Continuous Improvement, or a related regulated environment.
• Strong knowledge of cGMP requirements and pharmaceutical manufacturing operations.
• Experience with formulation, filling, lyophilization, and/or inspection processes.
• Experience managing CAPAs, Change Controls, quality investigations, and root cause analysis.

Skills

Validation

Pharma/Biotech

cGMP

Quality Systems

Continuous Improvement

Education

Bachelors degree

Tools

iShift

Qualipso

eBR

Opstrakker

Job description

Modis is seeking a Validation Engineer III for a contract role in Swiftwater, PA. The ideal candidate has solid pharma/biotech QA exposure and hands-on work with regulatory compliance.

The role focuses on cGMP operations, validation activities across formulation, filling, lyophilization, and investigations, and management of CAPAs and change controls. A Bachelor's degree and 3–5 years of relevant experience are required.