Senior Validation Engineer

Nestle Operational Services Worldwide SA•Lower Gwynedd Township, PA

1d•Onsite

About The Position

At Nestlé Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life®, Nature's Bounty®, Vital Proteins®, Orgain®, Nuun®, BOOST®, Carnation Breakfast Essentials®, Peptamen®, Compleat Organic Blends®, and more. We also have extensive pharmaceutical expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases. At Nestlé Health Science, we bring our best for better lives. Our people are challenged to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. We know brilliant ideas can come from anyone, anywhere. Here we embrace the entrepreneurial spirit and collaborate with teams that champion focused and forward thinking. We are committed to fostering professional growth and celebrating the achievements of our people along the way. We offer dynamic career paths, robust development, opportunities to learn from talented colleagues around the globe, and benefits that support physical, financial, and emotional wellbeing. Join us to innovate for impact and reimagine the future of health and nutrition for patients and consumers. 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.

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
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.

Nice To Haves

Familiarity with Kneat Gx or similar platform preferred
Familiarity with Blue Mountain Regulatory Asset Management or similar platform preferred.

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%.