Pharma Validation Project Lead - Quality & Compliance

Germer International; Bethlehem (Northampton County); On-site; USD 100,000 - 150,000; Full time

Job summary

Germer International is seeking a Validation Lead in the United States to oversee installations, qualification studies, and process validations across packaging, lab, and utility systems.

The role requires 4+ years in industry or regulatory/compliance with strong project management, cGMP knowledge, and collaboration skills to drive cross-functional teams and ensure regulatory submissions and inspections are supported.

Qualifications

• Bachelor’s degree or higher in a relevant scientific/technical field.
• Total combined years: 4+ years in industry or regulatory/compliance, with project mgmt experience preferred.
• Experience in project management.
• Well organized with keen attention to detail.
• Knowledge of state and federal pharmaceutical 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 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

Computer literacy

Collaboration

Project management

Education

Bachelor’s degree or higher in relevant field

Tools

Microsoft Outlook

Excel

Word

Job description

Germer International is seeking a Validation Lead in the United States to oversee installations, qualification studies, and process validations across packaging, lab, and utility systems.

The role requires 4+ years in industry or regulatory/compliance with strong project management, cGMP knowledge, and collaboration skills to drive cross-functional teams and ensure regulatory submissions and inspections are supported.