Process Architect

📋 Description

• Collaborate with customers to map legacy Word docs into Vault structures.
• Reconcile metadata to ensure data alignment across the validation lifecycle.
• Execute bulk data loads and manage staged data for workshops.
• Advise on best practices for importing and using Validation Management.
• Build and maintain digital record libraries for templates.
• Develop tooling and methods to migrate data across Vault environments.
• Deliver billable work across tiers from mapping to deployments.
• Partner with strategy and services to ensure a strong customer experience across validation.

🎯 Requirements

• 5+ years in life sciences validation with CSV/A and CQV lifecycle expertise.
• Customer-facing consulting/billable role; lead workshops and advise executives.
• Experience mapping processes into standardized data languages for paperless validation.
• Knowledge of risk-based qualification and standards (ASTM E2500, ISPE, Annex 15).
• Proficiency with bulk data loading tools and data integrity in cloud platforms.
• Analytical skills to identify gaps between legacy data and templates.
• Bachelor’s degree in Engineering (Chemical/Mechanical/Bioengineering/Electrical or related).
• Travel up to 30% domestically and internationally (typical ~15%).
• Nice to Have: Active participation or leadership in ISPE/PDA committees.
• Nice to Have: Experience leading large-scale digital validation implementations.
• Nice to Have: Change management experience in manufacturing/quality.
• Nice to Have: Familiarity with data transfer methodologies or migration tooling.

🎁 Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company paid holidays
• Retirement programs
• 1% charitable giving program