Summary:The Validation Engineer oversees the aseptic process simulations (media fills), equipment qualification and requalification, facility and utility qualification and requalification. This position supports Operations and Quality and will maintain a compliant schedule of validation activities and will serve as a technical resource in process improvement initiatives that require a validation expertise.
Essential functions:- Execute validation and qualification activities (equipment, media fills, facility, utility, environmental monitoring system) to include protocol preparation, scheduling execution, protocol execution, and final report preparation.
- Ensure that C&Q and Validation project deliverables (i.e., Specification, SOPs; Protocols/Reports; Risk Assessment; Traceability Matrix, etc.) are compliant with the current regulations, current industry practices, and internal policies and procedures.
- Maintain a revalidation / requalification lifecycle and executes accordingly per Standard Operating Procedures (SOPs).
- Execute airflow patterns (smoke studies) of compounding operations.
- Manage a schedule for outsourcing HEPA Filter recertification. Oversee and approve the outsourced activities.
- Effectively coordinate and communicate all due validation/qualification activities with relevant functional groups to enable compliance to the validation / qualification schedule.
- Develops/improves validation and qualification programs as needed to remain current with cGMP's and industry standards.
- Represent validation in teams assembled to procure, install, troubleshoot systems, equipment, and processes.
- Conduct and/or participate in deviation investigations as appropriate to identify root causes and define corrective and/or preventative actions (CAPA).
- Drive CAPA's assigned to the validation department
- Generate and approve SCA Certificate of Compliance
Requirements
Required Qualifications & Experience:- Bachelor's degree in life sciences, engineering, or related discipline.
- 5+ years of direct validation experience in pharmaceutical and/or life sciences.
Desired Knowledge, Skills, and Abilities:- Proficient in MS Word, Excel, and PowerPoint
- Have effective communication (both written and verbal).
- Demonstrated strong technical writing skills, decision making abilities and critical thinking.
- Demonstrated knowledge and understanding of cGMP's, industry guidance associated with aseptic processing, CAPA, root-cause analysis, risk assessment and investigation tools and techniques.
- Knowledge and experience in leading aseptic process simulations (media fills)
