Senior Specialist, Associate Aseptic Process Validation Engineer

Shifts Available: Monday–Friday, Standard Working Hours Responsibilities: Support execution of Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications. Author qualification/validation documents (procedures, protocols, summary reports) and ensure Manufacturing readiness for APS execution. Participate in/lead aseptic risk assessments; author associated summary reports. Author product impact assessments for Personnel and Environmental Monitoring-related deviations. Lead/own site Change Controls as required; support investigations and global change controls as required. Ensure safe, compliant cGMP operations; maintain inspection readiness and support regulatory inspections as a Subject Matter Expert. Serve as an MS&T representative on cross-functional/multi-site teams and build collaborative relationships to influence product/process life cycle programs. Knowledge & Skills: Experience with cGMPs and multinational biopharmaceutical/cell therapy regulations. Experience in aseptic processing/validation and facility/clean room design. Experience with internal and health authority audits. Excellent verbal and written communication. Basic Requirements: Bachelor’s degree in science, engineering, biochemistry, or related field (or equivalent). Minimum 2 years’ experience in biopharmaceutical operations (or equivalent). Compensation/Benefits (as listed): Devens, MA, US: $87,660–$106,224. Health coverage (medical/pharmacy/dental/vision), wellbeing support, 401(k), disability and life insurance; PTO options per employment type. #J-18808-Ljbffr Scorpion Therapeutics