Validation Engineer
LocatValidation Engineer
Location: Summit, NJ
Job Description:
We are looking for a meticulous and dedicated Validation Engineer to join our team. The successful candidate will primarily focus on temperature mapping activities using Kaye validators, helping to ensure the compliance of our processes and products with regulatory standards and organizational quality.
Key Responsibilities:
Perform temperature mapping of facilities, equipment, and processes using Kaye validator instruments.
Assist in the development and execution of validation protocols for thermal studies including autoclaves, ovens, freezers, refrigerators, stability chambers, and warehouses.
Interpret, analyze and report data findings from temperature mapping exercises and present the data in a clear and concise manner.
Ensure all validation activities and results are documented and compliant with standard operating procedures (SOPs), Good Manufacturing Practices (GMPs) and regulatory guidelines.
Support in the validation of HVAC and other environmental systems.
Participate in periodic reviews of validated systems.
Work cross-functionally with the Quality and Production teams to identify process improvements and address validation concerns.
Qualifications and Requirements:
A degree in Engineering, Life Sciences, or related field.
Prior experience in a regulated industry, ideally pharmaceutical or medical device industry, with a focus on validation activities.
Hands-on experience with Kaye validator instruments.
Demonstrated understanding of temperature mapping techniques and regulatory requirements.
Proficiency in data analysis and technical report writing.
Strong problem-solving skills, attention to detail, and the ability to work independently or as part of a team.
Good understanding of GMP, ISO, and other regulatory standards applicable to the pharmaceutical or medical device industries.
Preferred Qualifications:
Certification in validation technology or a related field.
Familiarity with FDA, EMA and other international regulations and guidelines.
Experience with other validation systems and equipment.
Please email tony@scientificsearch.com
#LI-TD1
ion: Summit, NJ
Job Description:
We are looking for a meticulous and dedicated Validation Engineer to join our team. The successful candidate will primarily focus on temperature mapping activities using Kaye validators, helping to ensure the compliance of our processes and products with regulatory standards and organizational quality.
Key Responsibilities:
Perform temperature mapping of facilities, equipment, and processes using Kaye validator instruments.
Assist in the development and execution of validation protocols for thermal studies including autoclaves, ovens, freezers, refrigerators, stability chambers, and warehouses.
Interpret, analyze and report data findings from temperature mapping exercises and present the data in a clear and concise manner.
Ensure all validation activities and results are documented and compliant with standard operating procedures (SOPs), Good Manufacturing Practices (GMPs) and regulatory guidelines.
Support in the validation of HVAC and other environmental systems.
Participate in periodic reviews of validated systems.
Work cross-functionally with the Quality and Production teams to identify process improvements and address validation concerns.
Qualifications and Requirements:
A degree in Engineering, Life Sciences, or related field.
Prior experience in a regulated industry, ideally pharmaceutical or medical device industry, with a focus on validation activities.
Hands-on experience with Kaye validator instruments.
Demonstrated understanding of temperature mapping techniques and regulatory requirements.
Proficiency in data analysis and technical report writing.
Strong problem-solving skills, attention to detail, and the ability to work independently or as part of a team.
Good understanding of GMP, ISO, and other regulatory standards applicable to the pharmaceutical or medical device industries.
Preferred Qualifications:
Certification in validation technology or a related field.
Familiarity with FDA, EMA and other international regulations and guidelines.
Experience with other validation systems and equipment.
Please email tony@scientificsearch.com
#LI-TD1