In thei role you will:

Coordinates and executes qualification and requalification of equipment and utilities used for manufacturing and packaging 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 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.

Write and execute 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

Review of products/ processes/ and equipment for determination of status in Validation Life Cycle

The Validation Engineer is a critical step in the development towards more senior technical and operations roles. A typical career progression looks like the following:

Validation Engineer ior Validation Engineer ager, Validation / Process Engineering chnical Manager

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

This role is responsible in:

• Support the overall validation and compliance efforts for the Salt Lake 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 over the counter products and dietary supplements based on Capital Expenditure Authorization (CEA), equipment operation manuals, and physical equipment.
• 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 interaction with governmental agencies and customers, 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 three years' experience in Process Engineering, Validation, Quality Assurance or Quality Control in an FDA regulated manufacturing or processing environment.
• Must have a minimum of 3 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. Minitab a plus
• 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
• Experience in Change Controls, Deviations, and Risk Assessments; TrackWise preferable
• Knowledge and expertise in FDA regulations; CFR 21 Parts 110, 111, 210, and 211

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.