Process & Validation Project Manager

About the Company

LAPORTE is a consulting engineering firm with 25 years of experience and a strong presence in North America and Europe. We specialize in delivering innovative solutions for the pharmaceutical and food & beverage industries.

Responsibilities

• Plan, coordinate, and execute facility improvement projects including scope definition, scheduling, and contractor coordination
• Serve as the primary on-site liaison for project activities to ensure minimal disruption to GMP operations
• Author and manage change control records through the site quality management system (QMS)
• Coordinate vendor approval and qualification processes for new contractors and service providers
• Develop and maintain project schedules, status trackers, and progress reports
• Identify and escalate project risks, scope changes, and schedule impacts
• Ensure compliance with GMP regulations, site SOPs, EHS requirements, and local building codes

Requirements

• Bachelor's degree in an engineering field or relevant equivalent
• Minimum 5 years of experience preparing and executing equipment qualification documents (IQ/OQ/PQ)
• Excellent knowledge of Current Good Manufacturing Practices (cGMP)
• Strong technical knowledge and project management skills
• Ability to travel to client sites as required

Preferred Qualifications

• Experience performing GxP risk assessments (FRA or FMEA)
• Experience in Aseptic Processing
• Familiarity with Computerized Systems Validation, ISPE GAMP5, and 21 CFR Part 11