Process Validation Engineer

The Process Validation Engineer is principally responsible for testing. They establish validation standards, develop testing protocols, prepare equipment, document test results, and maintain records for later analysis. They interact with individuals in operations, manufacturing, and product development, who will be affected by testing.

Duties & Responsibilities:

• Develop, prepare, and execute validation protocols to challenge various types of processes for qualification of PCM (phase change material) conditioning and related operations processes.
• Conduct Installation and Operational Qualification on refrigeration equipment and characterize its ability to meet defined acceptance criteria.
• Manage process parameters for PCM conditioning for all company on and off-site locations along with third party suppliers.
• Execute test protocols located on and off-site company warehouse locations.
• Author validation test reports post execution of protocols to include analysis of results, final conclusions, and recommendations.
• Prepares product and process reports by collecting, analyzing, summarizing information and trends and updates KPI’s.
• Coordinates validation activities associated with validation protocols with third party suppliers.
• Provide recommendations for process proposals based on experimental results and researched legacy data.
• Develop work instructions and standard operating procedures to reflect qualified processes and procedures.
• Develop and/or assist in the creating of new data analysis tools to aid in the understanding of product performance.
• Attend meetings with production, engineering, quality assurance and research and development personnel to obtain the necessary information for protocol preparation.
• Organize and execute, start to finish, full validation packages for new or existing programs.
• Review legacy data and organize and coordinate revalidation requirements.
• Perform preventative maintenance, maintenance of testing equipment and oversee an inventory of validation supplies.
• Perform additional special projects as needed to support product release and/or technical service investigation activities.
• Be willing to act with a sense of urgency and take ownership of the work assigned.
• Maintain a high level of organization and consistency with cleanliness in regard to a laboratory setting, material inventory, electronic data storage, spreadsheets, and project files.

Required Skills:

• Technical Bachelor’s degree
• 5 to 10 years’ relevant work experience
• Previous Test and Validation experience
• Knowledge with IQ/OQ/PQ methodologies
• Excellent Microsoft Office (Word, Excel, Access, PowerPoint etc.) skills
• Outstanding communication (written & verbal) and presentation skills
• Strong attention to detail and organizational skills
• Excellent problem solving and analytical skills
• Ability to manage multiple priorities and adapt to changing priorities
• Self-motivated and driven to exceed goals
• Likes autonomy and accountability; being comfortable with both

Desired Skills:

• Extensive experience with IQ/OQ/PQ methodologies
• Experience with Microsoft Excel Macros
• Experience with Solidworks, LabView, thermal modeling software
• Familiarity with ISO9001:2015, and OSHA Safety Standards
• Experience with Six Sigma, a plus

Travel & Availability

Up to 20% travel may be required, project based.

Physical Requirements

Required to stand, walk, reach with hands and arms, bend, stoop, kneel, and crouch and lift and/or move up to 50 pounds. Required to work in either a warehouse, manufacturing, or office environment for up to eight hours a day. While performing the duties of this job, frequently will be required to sit; type; use hands to finger, handle or feel objects, tools, or controls (some repetitive motion); and talk or hear.

Tools & Equipment:

Test Equipment: temperature loggers, temperature controllers, thermocouples, thermometers.

Office Equipment: Personal Computer, printer/scanner/copier, and barcode scanners

Laboratory Equipment: General hand tools, power tools, cutting knives, low voltage electrical wiring, pallet jack, and tape dispenser

Environmental Factors:

50/50 Office and storage warehouse environment

Use of PPE for hearing, eye and thermal protection

Work Remotely:

No

Equal Employment Opportunity Policy:

AeroSafe Global provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.