Process Validation Engineer

Avantor • Littleton, MA

425d

About The Position

The Process/Validation Engineer at Avantor is responsible for optimizing biopharma production processes, ensuring compliance with company policies, and implementing process improvements. This role involves managing resources, writing standard operating procedures (SOPs), troubleshooting equipment, and conducting data analysis to enhance manufacturing efficiency. The engineer will collaborate with scientists and other stakeholders to support the development and execution of validation protocols, contributing to life-changing advancements in medicine and healthcare.

Requirements

• Bachelor's degree in a relevant field.
• 4+ years of experience in process optimization and validation in a biopharma or manufacturing environment.
• Experience with lean manufacturing practices and the Toyota Production System (TPS).
• Familiarity with six sigma process improvement methods (Green Belt preferred).
• Experience in writing SOPs and training documents.
• Ability to conduct risk assessments (e.g., PFMEA, FMEA, 5WHYs).
• Experience in developing and executing validation protocols for equipment and processes.
• Knowledge of biopharma manufacturing processes and cleanroom environments.
• Advanced software application skills (e.g., Access, Visio, Minitab).
• Experience with collaboration tools (e.g., MS Office Suite).
• Experience in a regulated environment (FDA or ISO 9001 preferred).
• Project management experience in GMP manufacturing.

Nice To Haves

• Experience in conducting risk assessments (e.g., PFMEA, FMEA, 5WHYs).
• Familiarity with biopharma manufacturing processes.
• Experience in cleanroom environments.
• Advanced software application skills (e.g., Access, Visio, Minitab).
• Experience with collaboration tools (e.g., MS Office Suite).
• Direct applicable experience in project management.

Responsibilities

• Manage the optimization of resources and processes in compliance with company policies/procedures.
• Write SOPs and training documents to establish standard work and develop initial documents for new processes and systems.
• Troubleshoot equipment and hardware.
• Manage data through data collection, modeling, and analysis.
• Conduct cost/benefit analysis, process mapping, and problem analysis.
• Implement process improvements to meet quality standards.
• Design and conduct feasibility studies.
• Develop and execute validation of equipment and processes.
• Create required documentation and aid in team communication.
• Analyze production and support other areas as needed while identifying problems and developing countermeasures.

Benefits

• Diverse, equitable, and inclusive culture.
• Learning experiences to support career growth and success.
• Opportunities to contribute to life-changing science and healthcare advancements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees