Pharma QA Validation Engineer: Process & Compliance Leader

Piramal Pharma Limited; Bethlehem (Northampton County); Hybrid; USD 95,000 - 135,000; Full time

Job summary

Piramal Pharma Limited, a global leader in critical care solutions, seeks a QA Validation Engineer for our Bethlehem, PA site. You will drive cGMP compliance, own the site validation program, and coordinate with manufacturing, engineering, and QA/QC to qualify processes, equipment, and systems.

The role requires a Bachelor’s degree and 4+ years in pharma validation or regulatory/compliance, with strong project management and communication skills.

Qualifications

• Bachelor’s degree or higher in relevant scientific/technical field.
• Total combined years: 4 or more 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 the various state and federal pharmaceutical validation laws and legislations that are enforced from time to time

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

Regulatory compliance

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 Pharma Limited, a global leader in critical care solutions, seeks a QA Validation Engineer for our Bethlehem, PA site. You will drive cGMP compliance, own the site validation program, and coordinate with manufacturing, engineering, and QA/QC to qualify processes, equipment, and systems.

The role requires a Bachelor’s degree and 4+ years in pharma validation or regulatory/compliance, with strong project management and communication skills.