Quality Validation Engineer

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

Essential Duties and 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

Key Competencies (knowledge, skills and abilities every person must possess to be successful)

• cGMP and Regulatory Compliance - Strong understanding of pharmaceutical cGMP, industry standards, and regulations to make sound regulatory interpretation, lead and/or conduct investigations, employ logic, and implement decisions from within the Quality Assurance organization
• Professional Communication - Excellent verbal and written communication skills with the ability to interact across functions, departments, and seniority levels
• Computer Literacy - Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems
• Collaboration - Utilize teamwork and problem solving skills across all departments and internally to Quality Assurance
• Project Management - The ability to lead projects in relation to all quality functions including identify issues, initiate successful corrective actions, and completion of all tasks in timely manner

Education / Experience

• 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