Job Title: Validation Engineer

Job Description

Provide support in performing equipment, facility, and utility qualification activities to ensure compliance with cGMP and quality requirements.

Responsibilities

• Assist in the preparation and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment, facility, utilities, and related software.
• Support process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges, and challenge test criteria to technical service.
• Conduct field execution of validation deliverables, resolve any deviations, and author reports.
• Assist in maintaining validation process improvement projects.
• Author, review, and update appropriate SOPs.
• Follow Pharmaceutical industry standards in generating and updating supporting documentation such as P&IDs, material and equipment specifications, and requirement specifications.
• Work within cross-functional teams and communicate progress effectively to other team members and validation management.

Essential Skills

• Experience with equipment validation
• Knowledge of solid dosage forms
• Understanding of GMP
• Experience with facility qualification

Additional Skills & Qualifications

• BA degree in Engineering or Science
• 1 year of equipment validation experience
• 1 year of experience working in a solid dosage pharmaceutical company