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Validation Engineer Manager

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Supply
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United States
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Summary
  • Provides oversight, and planning of Validation activities, Site Validation Master Plan, including validation status matrix for key equipment, processes, and products for site.  This includes revalidation of same key equipment, processes, and products for site. 
  • Maintains up to date knowledge of key regulatory guidance/requirements for Validation, Continuous Validation, and Re-validation of key equipment, processes, and products for both VMS, and OTC operations.
  • Has responsibility over 1 – 3 validation team members to ensure Validation activities are completed on time for key equipment, process, and products
  • Coordinates qualification and requalification of equipment and utilities used for manufacturing and packaging equipment with Project Engineering as outlined in the Master Validation Plan.
  • Coordinate with Production, Quality, Maintenance, and other personnel as needed to manage projects, capacity increases, and process improvements.
  • The staff member will be responsible to work with Project Engineering, Process Engineering, and Project Manager teams to support, plan, manage, and execute the start-up, commissioning, and validation of new equipment, the creation of company cleaning and process validation master plans, and other projects.
  • Develop templates for Installation, Operational, and Performance Qualifications (IQ/OQ/PQ’s) for use by Project and Process Engineering teams. 
  • Support the Project and Process Engineering teams in writing and execution of validation protocols, such as Installation, Operational, and Performance Qualifications (IOPQs),  Process Validations (PVs) and Cleaning Validations (CVs).
  • Provide support and troubleshooting to manufacturing operations as well as identify process improvements and capacity constraints and design and execute projects to support corporate goals.
  • Projects and duties will be completed in compliance with applicable cGMP, FDA, TGA, USP and all other regulatory agencies standards

 

 

A fantastic opportunity is available for a Validation Engineer Manager to join our Technical team.

  

 

Responsibilities

 

 

  • Drive the overall validation and compliance efforts for the Salt Lake site.  Maintaining SOP’s, Site Validation Master Plan, including Validation Status Matrix for key equipment, processes, and products for the SLC site.
  • Generating and executing protocols, such as Installation, Operational, and Performance Qualifications (IOPQs), Process Validations (PVs) and Cleaning Validations (CVs).
  • Assists Project Engineers in defining any requirements and Factory Acceptance Test (FAT) and executes FAT is required.
  •  Writes qualification documents for existing and new equipment and utilities used for manufacture and packaging of dietary supplements, and OTC products, based on Capital Expenditure Authorization (CEA), equipment operation manuals, and physical equipment.
  • Oversees 1 – 3 validation team members to ensure all validation activities are completed on time, and the validation status of key equipment, processes, and products is maintained.
  • Schedules the execution with department leads and executes the protocols
  • Reviews qualification data, prepares reports, and makes recommendations for changes and/or improvements.
  •  Arranges for requalification of equipment as needed.
  • Manages change control for qualification related documents and executed protocols
  • Maintains appropriate validation documentation and files.
  • Manages, and leads interaction with governmental agencies and customers for validation component of SLC operation, as required.
  • Investigate process and quality problems and implement corrective actions
  • Identify and define project and process improvement opportunities
  • Develop project plans and timelines. Track project goals
  • Ensure that the elements or functions that are regulated by the cGMPs for equipment, facilities, computer systems, manufacturing processes and packaging processes meet the regulatory requirements.
  • Support the site change management process by assessing the impact of changes on the validation status of the equipment.  
  • Follow industry standards in generating and updating supporting documentation such as P&IDs, material and equipment specifications, and requirement specifications
  • Work within cross functional teams
  • Communicate progress effectively
  • Maintain safe working environment
  • Follow company policies and procedures

 

Is this You?

  • Must have a Bachelor’s degree in a scientific field such as, but not limited to, Chemical Engineering, Chemistry, Biology, or Biochemistry, or at least five years’ experience in Process Engineering, Validation, Quality Assurance or Quality Control in an FDA regulated manufacturing or processing environment.
  • Must have a minimum of 5 years of validation experience
  • Ability to work over eight hours a day when needed.
  • Computer Literacy, especially with the Microsoft Office Suite products.
  • Strong communication skills in both a written and verbal manner
  • Superior ability to analyze data and generate conclusions based upon the data
  • Excellent interpersonal and problem solving skills in dynamic environment.
  • Strong organizational skills.
  • Strong capability in the use of statistical tools to develop sampling plans.
  • Ability to manage multiple priorities within established project deadlines.
  • Ability to work/crawl in confined spaces.
  • Ability to stand, stoop, bend, sit for long periods of time.
  • Ability to work in an environment that requires a respirator.
  • Ability to work with other functional area team members that do not have the same business focus as the process engineering


 

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly Global organisation.

 
 

Apply Now for a chance to really change the game!


 

 
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

 

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