Senior Validation SME - Aseptic Process Simulation

Tunnell Consulting, looks for top consultants on behalf of our Pharmaceutical/Biotech clients.  Currently, one of our client's needs a Senior Validation SME - Aseptic Process Simulation.  This is a 3-6 month contract role.  Work to be performed Onsite.  Client is based in the Greater Columbus, OH area.

Title:  Senior Validation SME – Aseptic Process Simulation

The Senior Validation SME is responsible for improving the company's Aseptic Process Simulation (APS), or Media Fill, program. This role develops and manages strategies, validation plans, and testing methods to ensure sterile manufacturing processes consistently meet regulatory and quality requirements.

The position works closely with Manufacturing, Quality Assurance, Engineering, Microbiology, and other teams to plan, execute, analyze, and continuously improve media fill studies. The specialist also serves as the primary contact for regulatory agencies regarding aseptic process simulation activities.

Additionally, the role supports process validation programs to ensure manufacturing processes are reliable, compliant, and capable of consistently producing high-quality products.

Key Responsibilities

• Develop and maintain the overall Media Fill (APS) strategy, including risk-based worst-case scenarios.
• Define simulation requirements and interventions based on regulatory expectations and industry standards.
• Plan, oversee, and document media fill studies from start to finish.
• Investigate deviations, perform root cause analyses, and initiate corrective actions or revalidation when necessary.
• Partner with Manufacturing, Quality Assurance, Engineering, MS&T, Microbiology, and Quality Control teams.
• Incorporate Environmental Monitoring (EM) data into the APS program.
• Ensure validation activities comply with GMP requirements and global regulations.
• Support audits, inspections, regulatory submissions, and responses to health authorities.
• Develop and manage Process Performance Qualification (PPQ) and Continued Process Validation (CPV) programs.
• Create and maintain validation procedures, protocols, reports, templates, and work instructions.
• Perform hands-on validation work, including protocol writing, execution, data analysis, and report preparation.

 General Expectations

• Demonstrate integrity, accountability, and sound judgment.
• Maintain a positive, professional attitude.
• Follow all regulatory requirements related to cell and gene therapy products.
• Pay close attention to detail and quality.
• Work independently with minimal supervision while meeting project objectives.
• Manage multiple projects, investigations, and documentation assignments simultaneously.
• Identify, solve, and prevent operational problems.
• Support audits, customer interactions, and inspection readiness activities.

Qualifications

• Bachelor's, Master's, or Ph.D. degree in Life Sciences, Biotechnology, Gene Therapy, or a related field.
• 5–8 years of relevant experience, including at least 3 years supporting commercial drug product filling operations.
• Strong expertise in:
• • Aseptic Process Simulation (Media Fills)
  • Process Validation
  • Contamination Control
  • Risk Assessment and Analysis

• Knowledge of GMP regulations and industry standards, including FDA, EU GMP Annex 1, PIC/S, and ISO 13408-1.
• Understanding of sterilization, aseptic processing, and first-air principles.
• Experience in biologics or gene therapy manufacturing, preferably with isolator technology or other closed systems.
• Strong communication, project management, and organizational skills.
• Proficiency in Microsoft Office (Word, Excel, and PowerPoint).
• Ability to work effectively both independently and within cross-functional teams.
• Strong customer focus and ability to handle confidential information professionally.