Principal Validation Specialist - Remote

Overview

Lonza is seeking a Principal Validation Specialist to ensure software validation processes meet regulatory standards and drive efficiency in pharmaceutical manufacturing. This role is 100% remote, with a preference for candidates on the East Coast.

In Short

• Lead validation packages for commercial software releases.
• Develop strategies for software validation compliance.
• Generate documentation for validation activities.
• Manage client-facing documentation updates.
• Execute computer validation documentation for software releases.
• Collaborate with QA and Product Delivery teams.
• Support regulatory inspections and audits.
• Implement corrective actions for audit responses.
• Evaluate impact of software changes on validation documents.
• Work in a fast-paced, dynamic environment.

Requirements

• Minimum 7 years of experience in life sciences.
• Experience managing multiple validation projects.
• Thorough understanding of Life Cycle Validation approach.
• Knowledge of cGMP automation/computerized systems.
• Familiarity with GAMP 5 and 21 CFR Part 11.
• Proven team management and communication skills.
• Attention to detail in reviewing technical documents.
• Self-motivated and adaptable.
• MODA / LIMS / MES experience is a plus.

Benefits

• Competitive salary range of $100,000.00 – $170,000.00.
• Performance-related bonuses.
• Comprehensive benefits package including medical and dental coverage.
• 401k plan.
• Life insurance and disability insurance.
• Employee assistance program.
• Paid time off (PTO).
• Opportunities for growth and development.
• Work that positively impacts millions of people.
• Commitment to ethical practices and environmental respect.