Business Process Architect

Overview

Business Process Architect role focused on analyzing and designing new business processes, with a strong emphasis on Computer System Validation (CSV) and Computer Software Assurance (CSA) in a GxP-regulated environment. The role guides small teams through end-to-end validation activities and acts as the face of the compliance team.

What you'll do

• Analyze and design new business processes and create the documentation that guides implementation of new processes and technologies.
• Partner with the business to define product requirements and use cases to meet process and functional requirements.
• Participate in user and task analysis to represent business needs.
• Guide and manage small teams while actively performing and overseeing project validation activities.
• Act as the primary liaison for the compliance/validation team in internal meetings, gather data and report compliance metrics to management.
• Coach and mentor team members to ensure consistent execution of client workflows and project validation targets.
• Maintain an up-to-date understanding of FDA and other global regulatory guidelines.
• Develop and refine Standard Operating Procedures (SOPs) and Work Instructions.
• Support preparation for, participation in, and support of external regulatory audits.

What you'll need

• Minimum 5 years of experience is required.
• Must have skill: Computer System Validation (CSV).
• 15 years full time education is required.
• Bachelor of Engineering (BE) degree or an equivalent academic credential.
• Deep expertise in Pharmaceutical Regulatory Compliance and CSV/CSA across major regulatory bodies (e.g., FDA, EMEA).
• Comprehensive knowledge of full-cycle CSV within GxP environments, with extensive hands-on experience with the V-Model and the complete validation lifecycle.
• Strong grasp of pharmaceutical regulatory mandates, specifically 21 CFR Part 11 and GAMP5 guidelines.
• Proven ability to author, develop, and refine Standard Operating Procedures (SOPs) and Work Instructions.
• High level of GxP awareness, including strict adherence to Good Documentation Practices (GDP).
• Practical experience preparing for, participating in, and supporting external regulatory audits.
• Exceptional analytical capabilities paired with strong, clear communication skills.
• Demonstrated leadership qualities combined with effective problem-solving and troubleshooting abilities.
• Ability to collaborate with diverse teams and stakeholders to gather and validate requirements.
• Familiarity with regulatory and compliance considerations related to system validation.

Details

• Based at the Bangalore office.