Afton Scientific, LLC · 16 hours ago
MST Engineer (Relocation Provided)
Charlottesville, VA
Full-time
Onsite
Senior Level
5+ years expAfton Scientific, LLC is dedicated to advancing the quality and reliability of sterile pharmaceutical manufacturing. They are seeking an MST Engineer to lead the Manufacturing Science & Technology and Process Engineering functions, driving technical excellence and regulatory compliance in biopharmaceutical operations.
BiotechnologyManufacturing
Hiring Manager
Alison Passino
Responsibilities
Act as our resident in-house SME for our Isolators and Automatic Filling lines
Oversee process engineering for sterile finish operations, including process design, optimization, troubleshooting, and lifecycle management
Ensure robust execution of equipment qualification activities (URS, DQ, IQ, OQ, PQ) and maintain documentation compliance
Develop and implement manufacturing strategies for scale-up, process robustness, and yield improvement
Lead process validation, cleaning validation, and continuous improvement initiatives
Own change control strategy and ensure appropriate impact assessments for equipment, process, and utility modifications
Support technology transfer activities for clinical and commercial products
Collaborate with Quality, Manufacturing, and Regulatory Affairs to maintain audit readiness and drive compliance
Manage engineering capital projects, timelines, budgets, and vendor interactions
Drive operational excellence using Lean, Six Sigma, and structured problem-solving methodologies
Communicate technical updates, risk assessments, and project status to leadership and key stakeholders
Ensure equipment reliability through effective preventive maintenance, calibration, and lifecycle programs
Qualification
Required
Minimum five (5) years of experience in pharmaceutical or biotechnology manufacturing within GMP-regulated environments
Minimum 3 (three) years of experience with isolators, automated filling lines, and sterile utilities (WFI, clean steam, nitrogen, compressed air)
Demonstrated expertise in process validation (IQ/OQ/PQ), equipment qualification, and FDA Process Validation Guidance implementation
Strong working knowledge of FDA, EMA, ICH, and EU Annex 1/15 regulatory requirements
Experience developing, coaching, and managing engineering teams (we see this role growing)
Proficiency with engineering project management, equipment lifecycle management, and risk assessment tools (FMEA, HAZOP, QRM)
Exceptional communication skills with the ability to present technical concepts to executive teams and external partners
Preferred
Bachelor's degree in engineering (Chemical, Mechanical, Industrial, or related field); master's degree preferred
Experience working in a CDMO or multi‑product aseptic manufacturing environment
Lean/Six Sigma certification (Green Belt or Black Belt)
Experience supporting product commercialization and technology transfer
Company
Afton Scientific, LLC
Afton Scientific, a recognized leader in sterile injectable manufacturing and contract development and manufacturing organization (CDMO) services, distinguishes itself through unwavering commitment to quality, reliability, and transformative innovation.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2024-01-30Acquired
Leadership Team
Thomas Thorpe
CEO
Recent News
2024-04-26
2024-04-26
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