Process Project Manager

Role Overview

Perform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients. Develop risk assessment, system impact assessments, protocols and reports that support the qualification and validation requirements in the industry.

What You Will Do

Develop validation protocols, review and analyze system and process performance data, investigate deviations, and create summary reports. Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Why It Might Be a Fit

Ideal candidate has at least 3 years of experience in several functions in the pharmaceutical industry, including commissioning, qualification, validation, quality systems, quality operations, manufacturing, engineering, and technology transfer.

Requirements

• Bachelor's degree in technical discipline such as Engineering or Science
• 3 or more years of experience in several functions in pharmaceutical industry
• Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4 and other regulatory requirements
• Experience with investigations into manufacturing / laboratory deviations and determination of product impact potential, root cause and corrective/preventive actions

Benefits

• Consulting roles with international healthcare clients in strategically relevant projects
• Opportunity to take on leadership responsibilities and to help shape our organization
• Excellent career development and growth opportunities in a growing premier consulting organization
• Structured training program and peer mentoring system to support competence and personal growth