Senior Aseptic Validation Engineer — cGMP Compliance & QA

Socket.dev; Windsor (CT); On-site; USD 95,000 - 140,000; Full time

Job summary

SCA Pharma in Windsor, CT is seeking a Validation Engineer to oversee aseptic process simulations, equipment qualification, and facility validation. You will maintain a compliant schedule and serve as a technical resource for process improvement within Operations and Quality.

The role requires a life sciences or engineering degree and 5+ years of direct validation experience in pharma, with strong knowledge of cGMP, CAPA, risk assessment, and investigation tools.

Qualifications

• Bachelor’s degree in life sciences, engineering, or related discipline.
• 5+ years of direct validation experience in pharmaceutical and/or life sciences.
• Proficient in MS Word, Excel, and PowerPoint.

Responsibilities

• Execute validation and qualification activities (equipment, media fills, facility, utility) with protocol prep and final report.
• Ensure C&Q and validation deliverables comply with regulations, industry practices, and SOPs.
• Maintain a revalidation/requalification lifecycle per SOPs.
• Execute airflow patterns (smoke studies) of compounding operations.
• Coordinate outsourcing and approve HEPA filter recertification activities.
• Develop/improve validation programs to stay current with cGMPs and industry standards.
• Represent validation in projects to procure, install, troubleshoot systems and processes.
• Conduct deviation investigations and define corrective/preventive actions (CAPA).
• Drive CAPAs assigned to the validation department.
• Generate and approve SCA Certificate of Compliance.

Skills

Effective communication

Technical writing

cGMP knowledge

Aseptic processing

CAPA

Root-cause analysis

Risk assessment

Investigation tools

Leadership in validation

Education

Bachelor's degree in life sciences or engineering

Tools

MS Word

MS Excel

MS PowerPoint

Job description

SCA Pharma in Windsor, CT is seeking a Validation Engineer to oversee aseptic process simulations, equipment qualification, and facility validation. You will maintain a compliant schedule and serve as a technical resource for process improvement within Operations and Quality.

The role requires a life sciences or engineering degree and 5+ years of direct validation experience in pharma, with strong knowledge of cGMP, CAPA, risk assessment, and investigation tools.