QA Validation Engineer — GMP & Validation Lead

Piramal Critical Care, Inc.; Bethlehem (Northampton County); On-site; USD 85,000 - 120,000; Full time

Job summary

Piramal Critical Care seeks a QA Validation Engineer to drive the site validation program and uphold cGMP compliance. You will own qualification activities for packaging, laboratory, and utility systems, coordinating with operations, QA/QC, and engineering to support capital projects.

The role requires a Bachelor’s degree in a scientific/technical field and 4+ years of industry experience, including project management.

Qualifications

• Bachelor’s degree in a relevant scientific/technical field.
• 4+ years in industry with project management experience.
• Knowledge of state and federal pharma validation laws.

Responsibilities

• Arranges, plans, manages and executes installations, operations and performance qualifications of packaging, laboratory and utility systems
• Schedules, plans, manages and executes studies for cleaning validations
• Schedules, plans, manages, and executes process validation studies and authoring related plans, summary reports and protocols
• Reviews and approves validation project documentation
• Coordinates and interfaces with the process unit heads, quality and engineering groups to ensure successful project executions
• Leads and coordinates cross-functional teams for project validation
• Priorities, manages and executes multiple projects utilizing the project management methodologies
• Oversees external validation resources
• Supports the development of best and proven validation practices in the validation department based on current industry guidelines and practices
• Authors relevant standard operating procedures for ensuring compliance with the company’s policies
• Supports regulatory submissions and also regulatory agency inspections whenever requested
• Champions continuous improvements in the validation department

Skills

cGMP compliance

Professional communication

Project management

Regulatory experience

Education

Bachelor’s degree

Tools

Microsoft Office

Job description

Piramal Critical Care seeks a QA Validation Engineer to drive the site validation program and uphold cGMP compliance. You will own qualification activities for packaging, laboratory, and utility systems, coordinating with operations, QA/QC, and engineering to support capital projects.

The role requires a Bachelor’s degree in a scientific/technical field and 4+ years of industry experience, including project management.