Validation Engineer - Team Leader
Job Description
Job Description
We are looking for a bright, energetic, and committed professional to work as a validation specialist in our New York facility. Dover Brook Associates will provide support and extensive training for the activities related to the exciting projects. This will allow growth in specialized fields of science and industry. The successful candidate will be responsible for performing routine microbiological and chemical procedures on food and pharmaceutical products and equipment according to company and standard methods.
Validation Engineer is needed to perform the following duties:
• Responsible for Technical packaging support and trials at pilot plant during commissioning of new Aseptic filling line- Quality Check of Bottles/closures/Polymer Sleeves and Food Product.
• Responsible for all Packaging validation activities in beverage industry by performing operational qualification of Aseptic equipment and recommend changes accordingly to qualify the process.
• Solid understanding of FDA validation guidelines and food industry best practices and be able to implement validation standards.
• Experience in Aseptic Processing, Formulation Filling and Packaging Equipment.
• Responsible for validation processes like- documenting commissioning activities, establishing the process, and developing and performing qualification studies to provide a high degree of assurance that equipment and processes will consistently produce quality product during production.
• Leader in Change control processes in validating the High or low acid food products.
• Write, execute, and review complex protocols and coordinate validation activities with project leader to support validation activities.
• Review, analyze and interpret system performance data for completed qualification and prepare final package to summarize data.
Other Responsibilities may include:
Performing a variety of validation tests and assays both at on-site locations and in the laboratory. The testing will be in accordance with established policies, procedures, and regulations including assisting in the preparation of protocols and reports; collection, organization, and analysis of data; and preparation of study results for presentation at meetings. The work will involve food and pharmaceutical products which include retort/autoclave and aseptic processing and packaging lines. Microbiological and chemical validation testing includes but is not limited to food spoilage analysis, standard plate count, spore count, serial dilution, titration, pH, and H2O2 residual testing. Knowledge of regulatory testing, evaluation, and validation of low-acid food aseptic processing equipment is a plus.
Additionally, the right person should be able to understand basic lab instructions and be able to follow microbiology test protocols and standard operating procedures, write up results, and summarize data. Must be willing to travel.
The position offers you an opportunity to contribute and professionally develop with an exciting, forward-thinking, and fast-moving company. We value the professional development of our employees and offer educational opportunities. DBA believes in team-building activities or work-sponsored events; the morale of our people is important. Our company adheres to the principle that employees should feel valued and satisfied with their projects.
Bachelor's Degree is required in Pharmaceutical Manufacturing or Packaging Sciences or Industrial Engineering.
Regional and International Travel Requirements:
Our Main Office is located in Chester, NY.
This position involves frequent travel, with an estimated 40-50% of your work time spent traveling regionally within the continental US and potentially on international trips.
Company DescriptionDover Brook Associates provides technical, regulatory, and engineering support worldwide to the food and drug industries. We offer a wide range of services but our specialty is in the area of sterile processes, with an emphasis on aseptic processing/packaging and retort systems.
Our project capabilities range from regulatory assistance, engineering design and support, thermal process development, microbiological testing, and product development to contract packing assistance and technical communication and training programs.
The company is an exciting, forward-thinking, and fast-moving company. We value the professional development of our employees and offer educational opportunities. DBA believes in team-building activities or work-sponsored events; the morals of our people are important. Our company adheres principle that employees should feel valued and satisfied with their jobs.
Company Description
Dover Brook Associates provides technical, regulatory, and engineering support worldwide to the food and drug industries. We offer a wide range of services but our specialty is in the area of sterile processes, with an emphasis on aseptic processing/packaging and retort systems.\r\n\r\nOur project capabilities range from regulatory assistance, engineering design and support, thermal process development, microbiological testing, and product development to contract packing assistance and technical communication and training programs.\r\n\r\nThe company is an exciting, forward-thinking, and fast-moving company. We value the professional development of our employees and offer educational opportunities. DBA believes in team-building activities or work-sponsored events; the morals of our people are important. Our company adheres principle that employees should feel valued and satisfied with their jobs.