Job Description:

The Process Engineer, Validation is responsible for optimizing processes by executing performance qualification, establishing process capabilities and ensuring adherence to standards through continuous process verification. This role will provide technical subject matter expertise and support for the Herbalife Innovation and Manufacturing site (HIM-WS).

 

DETAILED RESPONSIBILITIES/DUTIES:

 

• Responsible for supporting the Validation/Qualification program by:

1. 
   

   1. Develop and author validation/qualification protocols at the Herbalife Manufacturing facility for processes, equipment, facilities, and utility systems.

   
   

   2. Execute validation/qualification protocols for processes, equipment, facilities, and utility systems. at the Herbalife Manufacturing facility.

   
   

   3. Prepare validation/qualification summary reports for the executed protocols

   
   

• Support continuous improvement and CAPA (corrective action/preventive action) activities related to validation.




• Contribute to the generation and review of required documentation (SOP’s, Protocols, Change Requests/Change Controls) to support validation activities.




• Applies standard techniques and procedures to carry out a series of scientific and/or engineering tasks.




• Provide adequate reporting and communication of projects to project manager, stakeholders and/or department manager.




• Other duties as assigned.

REQUIRED QUALIFICATIONS:
 
Skills:

• Strong technical writing skills and experience in writing and executing IQ, OQ and PQs, Process Verifications (PVs), and Continuous Verification programs.


• Well-organized and technically sound in understanding validation principles.


• Strong technical writing skills with a thorough understanding of good documentation practices.


• Ability to provide consultation and input to support the manufacturing facility as it relates to the qualification or validation process.


• Ability to prioritize projects and manage assigned resources to meet organizational goals and objectives.


• Ability to track and update schedules to provide upper management visibility of milestones and achievements


• Ability to investigate and resolve OOS results, deviations or non-conformances.


• Technical aptitude and ability to work in fast paced environment with competing priorities.


• Ability to operate with minimal direction and supervision and be able to manage and track status of activities.


• Proficient with Microsoft Office Suite, Adobe, Project and Visio.


• Excellent teamwork, organizational, communication and problem-solving skills.

Experience:

 

• 3–5 years of related validation experience in a cGMP environment preferably in food/pharmaceutical based GMP manufacturing facility.


• Experience with equipment qualification methodologies


• Strong knowledge and experience in cGMP CA/PA, root cause analysis, risk assessment and investigation tools and techniques.

 

Education:

 

• Bachelor’s Degree in Science/Engineering

 

PREFERRED QUALIFICATIONS:

 
Skills:

• Strong statistical analysis background


• Strong problem-solving skills and ability to work collaboratively with cross functional groups to solve problems

Experience:

• Experience in establishing technical user requirements (URS)


• Experience in defining process capabilities and control limits to prevent process drifts and leveraging data to ensure standards and requirements are met


• Experience in formulation and/or process engineering

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