Engineer, Validation

Herbalife•Lake Forest, CA

2d•Onsite

About The Position

Join an award-winning team at one of Orange County's Top Workplaces! Herbalife at Lake Forest has been recognized by the OC Register for our exceptional workplace culture, and we're looking for a dedicated Engineer, Validation to help us maintain our world-class standards. This is your opportunity to play a critical role in ensuring the products that improve millions of lives around the world are manufactured with the highest level of quality, safety, and integrity. The Validation Engineer is responsible for all equipment and process validation activities at Herbalife Innovation and Manufacturing site, with primary focus at the Lake Forest location. Execution of validation activities is done to state and federal regulatory requirements, Herbalife and/or other applicable regulations and standards. The Validation Engineer supports all projects required for the expansion and improvement of operations at the production facility and coordinates all validation activities and projects with departmental managers. In this role, you will be empowered to take ownership, drive meaningful improvements, and be recognized as a trusted technical authority across the organization.

Requirements

3-5 years of validation/qualification and process engineering experience in a GMP environment.
5+ years of experience in Good Manufacturing Practices and Good Documentation Practices.
Experience in food, pharmaceutical and/or medical device process development.
Bachelor of Science in Chemistry or field of Engineering
Strong technical writing skills. Detailed knowledge of grammar, spelling, punctuation, and the fundamentals of technical GMP documentation.
Strong mechanical aptitude and process knowledge.
Ability to work independently with minimal supervision.
Knowledge of PLC and automated controls qualification.
Knowledge of qualification fundamentals and requirements for powder and liquid handling, processing, and packaging.

Nice To Haves

Basic experience with equipment cleaning and computer systems validation methodologies is a plus.
Experience in electronic validation systems is preferred but not required.
Openness to learning skills outside of validation but is required for the expansion and improvement of operations at the production facility.

Responsibilities

Facilitates validation/qualification projects (planning, scheduling, execution, project reports, etc.).
Creates validation protocols and summary reports in compliance with Herbalife standards and/or government regulations. This includes investigating and resolving protocol deviations in a timely manner.
Coordinates change control and equipment-related changes (this includes providing assessment and feedback regarding change requests for equipment, facility, process modifications, etc.).
Maintains SOPs related to validation/qualification (i.e. validation master plans, validation templates) and update them, as required, to meet current standards.
Acts as back-up for management of the Global Environmental Monitoring (EM) program, which includes acting as an administrator for the associated Vaisala viewLinc application and working with temperature & humidity data loggers.
Additional duties as assigned.
Be able to work effectively with interdisciplinary departments to meet project deadlines and serve as a validation authority consulting with Engineering, Operations, and Quality.