Lead Validation Engineer, Aseptic Processes & Compliance

SCA Pharma; Windsor (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

SCA Pharmaceuticals in Windsor, CT is seeking a Validation Engineer to oversee aseptic process simulations (media fills), equipment qualification and requalification, and facility qualification. This role supports Operations and Quality and ensures a compliant validation schedule and acts as a technical resource for process improvement.

The candidate will lead validation activities, prepare protocols and reports, maintain lifecycle for requalification, and drive CAPAs while contributing to

Qualifications

• Bachelor’s degree in life sciences, engineering, or related discipline.
• 5+ years of direct validation experience in pharmaceutical and/or life sciences.
• Strong technical writing skills and clear communication.
• Knowledge of cGMP, aseptic processing, CAPA, root-cause analysis, risk assessment and investigation tools and techniques.
• Ability to lead aseptic process simulations (media fills).

Responsibilities

• Oversee validation and qualification activities (equipment, media fills, facility, utility, environmental monitoring) with protocol prep, scheduling, execution, and final report creation.
• Ensure C&Q and validation deliverables comply with regulations, industry practices, and internal policies.
• Maintain a revalidation/requalification lifecycle per SOPs.
• Execute airflow pattern studies (smoke) for compounding operations.
• Manage outsourcing of HEPA filter recertification and oversee activities.
• Coordinate validation tasks with cross-functional teams to meet schedule.
• Develop/update validation and qualification programs to stay current with cGMPs and industry standards.
• Represent validation in teams for procurement, installation, and troubleshooting of systems.
• Contribute to deviation investigations to identify root causes and CAPA.
• Drive CAPAs within the validation department.
• Generate and approve Certificate of Compliance.

Skills

Communication

Technical writing

Critical thinking

Decision making

Education

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

Tools

MS Word

Excel

PowerPoint

Job description

SCA Pharmaceuticals in Windsor, CT is seeking a Validation Engineer to oversee aseptic process simulations (media fills), equipment qualification and requalification, and facility qualification. This role supports Operations and Quality and ensures a compliant validation schedule and acts as a technical resource for process improvement.

The candidate will lead validation activities, prepare protocols and reports, maintain lifecycle for requalification, and drive CAPAs while contributing to