Pharma QA Validation Engineer - Drive Validation Programs

piramalpharma; Town of Bethlehem (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Piramal Critical Care is seeking a QA Validation Engineer to drive cGMP compliance and the site validation program. You will own change management, validate processes, equipment, and systems, and liaise with operations, QA/QC, and engineering to advance capital projects and process improvements.

The role collaborates with multiple functions and supports regulatory submissions and inspections as required. A strong attention to detail and project management experience are essential.

Qualifications

• Bachelor’s degree or higher in a scientific/technical field.
• Total combined years: 4+ years within industry or Regulatory/Compliance, including project management experience preferred.
• Experience in project management.
• Must be well organized with a keen attention to detail.
• Knowledge of state and federal pharmaceutical validation laws and legislations.

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 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 project management methodologies.
• Oversees external validation resources.
• Supports development of validation practices in line with industry guidelines.

Skills

cGMP

Professional Communication

Computer Literacy

Collaboration

Project Management

Education

Bachelor’s degree or higher in relevant scientific/technical field

Tools

Microsoft Outlook

Excel

Word

Job description

Piramal Critical Care is seeking a QA Validation Engineer to drive cGMP compliance and the site validation program. You will own change management, validate processes, equipment, and systems, and liaise with operations, QA/QC, and engineering to advance capital projects and process improvements.

The role collaborates with multiple functions and supports regulatory submissions and inspections as required. A strong attention to detail and project management experience are essential.