Position Summary:
Reporting to the Senior Manager, Facilities, Engineering and Validation, the Senior Validation Engineer role includes aspects of traditional Validation, Facilities, and Operations Engineering disciplines in a GMP environment. You will be involved in supporting and maintaining the qualified state of facilities and equipment ensuring regulatory compliance at all times to ensure the release of Nestle pharma products to serve our patients.

This is an exciting opportunity for anyone who excels at active and creative problem solving. This role will be a key subject matter expert in GMP equipment validation and shipping validation and will own the equipment validation, requalification, and shipping validation programs.

This role requires not only a strong application of GMP principles, but curiosity and attention to details in a fast-paced environment.

Please note this role is an on-site position in Lower Gwynedd, PA with some travel to other internal sites.

Key Responsibilities:
• Perform GMP commissioning and qualification activities including the drafting and execution of Installation, Operation, and Performance Qualification and Requalification Protocols.
• Administrate and operate the Validation Management platform to develop and implement document templates, requalification schedules, and new platform capabilities.
• As program owner, update the equipment validation, requalification, and shipping validation programs to remain in compliance with current regulatory expectations
• Coordinate and execute validation and requalification activities on facility and laboratory equipment. Facilitate third-party execution of validation activities.
• Work with technical leads and third-party subject matter experts to troubleshoot facility and analytical equipment.
• Support execution of the Calibration, Maintenance, and Facilities programs supporting GMP commercial and clinical processes.
• Operate the Computerized Maintenance Management System (CMMS) for calibration, maintenance, and work order management of equipment and systems.
• Support and lead quality efforts including the drafting and implementation of change controls, deviations, CAPAs, and regulatory filings.
• Draft, revise, and own documents in the quality management system including SOPs, forms, lists, etc.
• Support and lead interdisciplinary projects to procure, install, commission, and qualify equipment and facility improvements on-time and on-budget.
• Effectively collaborate with cross-functional teams to develop and implement engineering solutions that enhance efficiency, reliability, and compliance of laboratory and Donor facilities.
• The travel requirement for the FEV role is < 20%.

Experience and Education Requirements:
• Bachelor's degree in a related engineering discipline or equivalent work experience.
• 5+ years of experience in validation in the pharmaceutical industry.
• Strong knowledge of GMP regulations and Equipment and Shipping Validation regulatory expectations
• Experience presenting equipment validation and requalification programs to regulatory authorities during GMP inspections
• Familiarity with Kneat Gx or similar platform preferred
• Familiarity with Blue Mountain Regulatory Asset Management or similar platform preferred.
• Technical writing skills, with strong understanding of technical validation and system documentation.
• Knowledge of analytical systems and facility equipment.
• Strong troubleshooting, analytical, and critical thinking skills.
• Effective communication skills, with the ability to collaborate across diverse teams.
• Ability to work independently and collaboratively in a dynamic, demanding environment.
• Ability to manage multiple priorities at once to meet project deadlines. #LI-SF1