Aseptic Process Validation Engineer

SCA Pharma; Poquonock (CT); On-site; USD 110,000 - 150,000; Full time

Job summary

SCA Pharmaceuticals is a dynamic rapidly growing company dedicated to providing high quality medications critical to saving and sustaining human life. The Validation Engineer will oversee aseptic process simulations (media fills), equipment qualification/requalification, and facility/utility qualification, supporting Operations and Quality with a compliant validation schedule.

This role requires a Bachelor's in life sciences or engineering, 5+ years of validation experience in pharma, strong

Qualifications

• Bachelor’s degree in life sciences, engineering, or related discipline.
• 5+ years of direct validation experience in pharmaceutical/life sciences.

Responsibilities

• Execute validation and qualification activities (equipment, media fills, facility, utility, environmental monitoring system) including protocol prep, scheduling, execution, and final reports.
• Ensure C&Q and validation project deliverables comply with current regulations and SOPs.
• Maintain revalidation/requalification lifecycle per SOPs.
• Execute airflow patterns (smoke studies) of compounding operations.
• Manage schedule for outsourcing HEPA filter recertification and approve activities.
• Coordinate validation activities with functional groups to maintain schedule compliance.
• Develop/improve validation programs to align with cGMPs and industry standards.
• Represent validation in teams for procurement, installation, troubleshooting, and process improvement.
• Conduct deviation investigations to identify root causes and drive CAPA actions.
• Generate and approve SCA Certificate of Compliance.

Skills

MS Word

Excel

PowerPoint

Communication skills

Technical writing

Critical thinking

cGMP knowledge

Aseptic processing knowledge

Education

Bachelor’s degree in life sciences, engineering, or related discipline

Job description

SCA Pharmaceuticals is a dynamic rapidly growing company dedicated to providing high quality medications critical to saving and sustaining human life. The Validation Engineer will oversee aseptic process simulations (media fills), equipment qualification/requalification, and facility/utility qualification, supporting Operations and Quality with a compliant validation schedule.

This role requires a Bachelor's in life sciences or engineering, 5+ years of validation experience in pharma, strong