Senior Validation Project Engineer

Germer International - Pharmaceutical Recruiting; Allentown (Lehigh County); On-site; USD 90,000 - 130,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting is seeking a senior validation professional in the United States to lead installations, operations and performance qualification programs for packaging, lab and utility systems, and to coordinate cross-functional teams.

The role emphasizes planning studies, authoring validation plans and reports, ensuring cGMP compliance, supporting regulatory submissions and inspections, and driving continuous improvement within the validation department.

Qualifications

• Bachelor’s degree or higher in a relevant scientific/technical field.
• Total combined years: 4+ years in industry or regulatory/compliance with PM experience.
• Experience in project management and validation activities.
• Excellent organizational skills with attention to detail.
• Knowledge of state and federal pharmaceutical validation regulations.

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 validation.
• Schedules, plans, manages, and executes process validation studies with related plans and reports.
• Reviews and approves validation project documentation.
• Coordinates with process unit heads, quality and engineering to ensure project success.
• Leads cross-functional teams for project validation.
• Manages multiple projects using PM methodologies.
• Oversees external validation resources.
• Supports development of validation practices based on industry guidelines.
• Authors SOPs to ensure policy compliance.
• Supports regulatory submissions and inspections as requested.
• Champions continuous improvements in the validation department.

Skills

cGMP Compliance

Regulatory Knowledge

Professional Communication

Computer Literacy

Collaboration

Project Management

Education

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

Job description

Germer International - Pharmaceutical Recruiting is seeking a senior validation professional in the United States to lead installations, operations and performance qualification programs for packaging, lab and utility systems, and to coordinate cross-functional teams.

The role emphasizes planning studies, authoring validation plans and reports, ensuring cGMP compliance, supporting regulatory submissions and inspections, and driving continuous improvement within the validation department.