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Validation Engineer

  • Location: Lake Forest, Orange, California
  • Job Type:Contract

Posted about 1 month ago

POSITION SUMMARY STATEMENT:

This Temp position will provide support in two (2) interdisciplinary functions: validation and environmental monitoring (EM). The Temp will author, review, and execute validation protocols and reports with guidance from senior level staff, and will work closely with the validation group to complete assignments on projects related to equipment/facility/utility qualifications and cleaning validations/studies at the Herbalife Innovation and Manufacturing site (HIM-LF). In addition, the Temp will be a back-up for environmental monitoring routine responsibilities and projects, such as collecting/reviewing monthly EM data reports, swapping out data loggers, and assisting with troubleshooting Vaisala viewLinc application requests from global sites.

DETAILED RESPONSIBILITIES/DUTIES:

Responsible for supporting the Validation/Qualification program by:
a. Develop and author validation/qualification protocols at the Herbalife Innovation and Manufacturing (HIM) facility for processes, equipment, facilities, and utility systems.
b. Execute validation/qualification protocols for processes, equipment, facilities, and utility systems at the HIM facility.
c. Prepare validation/qualification summary reports for the executed protocols with support and guidance from senior level staff.
Contribute to the generation and review of required documentation (SOPs, 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.
Support global Environmental Monitoring (EM) administrative tasks, such as troubleshooting Vaisala hardware, creating new user accounts, and configuring/generating report templates in the Vaisala viewLinc application.
Collect and review monthly Environmental Monitoring data reports for the Lake Forest site.
Perform logger swaps during calibration exchanges for Lake Forest and other sites as needed.
Other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

None

REQUIRED QUALIFICATIONS:

Skills:
Technical writing skills and experience in writing and executing IQ, OQ and PQs.
Ability to independently execute validation studies which includes protocol generation, protocol execution, report close-out.
Understanding of mechanical systems as they relate to manufacturing equipment, facilities equipment and cleaning systems.
Technical aptitude and ability to work in fast paced environment with competing priorities.
Proficient with Microsoft Office Suite, Adobe, Project and Visio.
Excellent teamwork, organizational, communication and problem-solving skills.
Must be highly motivated and able to learn technical aspects of interdisciplinary systems.
Experience:

1+ years of related validation experience in a cGMP environment preferably in food/pharmaceutical based GMP manufacturing facility.
Basic knowledge and experience in cGMP CA/PA, root cause analysis, risk assessment and investigation tools and techniques.

Education:

Associate Degree in Science/Engineering/Quality or related technical field with 3+ years of work experience
Bachelors Degree in science/Engineering/Quality or related technical field with 1-3 years of work experience

PREFERRED QUALIFICATIONS:

Skills:
Knowledge and understanding of validation lifecycle and principles
Strong mechanical & technical aptitude
Experience working in a GMP environment
Experience working with temperature mapping and monitoring
Experience:
Experience working in a GMP environment and familiar with Good Documentation Practices (GDP)
Experience with equipment qualification methodologies
Experience with temperature mapping and/or monitoring