Validation Engineer

About the role

SCA Pharmaceuticals is a dynamic, rapidly growing company of passionate individuals committed to providing high-quality medications critical in saving and sustaining human life. As an FDA 503B outsourcing facility, SCA Pharma delivers customized medications to hospitals and healthcare facilities across the United States through unyielding quality, safety, and integrity.

The Validation Engineer oversees aseptic process simulations (media fills), equipment qualification and requalification, facility and utility qualification and requalification. This position supports Operations and Quality, maintains a compliant schedule of validation activities, and serves as a technical resource in process improvement initiatives requiring validation expertise.

Responsibilities

• Execute validation and qualification activities (equipment, media fills, facility, utility, environmental monitoring system), including protocol preparation, scheduling, execution, and final report preparation.
• Ensure C&Q and Validation project deliverables (e.g., Specifications, SOPs, Protocols/Reports, Risk Assessments, Traceability Matrix) comply with current regulations, industry practices, and internal policies.
• Maintain a revalidation/requalification lifecycle and execute according to Standard Operating Procedures (SOPs).
• Execute airflow patterns (smoke studies) of compounding operations.
• Manage a schedule for outsourcing HEPA Filter recertification and oversee/approve outsourced activities.
• Coordinate and communicate all due validation/qualification activities with relevant functional groups to ensure compliance with the schedule.
• Develop and improve validation and qualification programs to remain current with cGMPs and industry standards.
• Represent validation in teams assembled to procure, install, and troubleshoot systems, equipment, and processes.
• Conduct and/or participate in deviation investigations to identify root causes and define corrective/preventative actions (CAPA).
• Drive CAPAs assigned to the validation department.
• Generate and approve SCA Certificates of Compliance.

Requirements

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

Skills

• Proficient in MS Word, Excel, and PowerPoint.
• Effective communication (both written and verbal).
• Strong technical writing skills, decision-making abilities, and critical thinking.
• Demonstrated knowledge and understanding of cGMPs, industry guidance for aseptic processing, CAPA, root-cause analysis, risk assessment, and investigation tools.
• Experience leading aseptic process simulations (media fills).