Curia Global Inc. (Burlington, MA) seeks a Validation Engineer III for its Burlington, MA location. The position is responsible for developing and executing validation and revalidation protocols for processes, equipment, utility, and computer software validation. Work with Engineering and Facilities personnel to ensure proper installation and operation of systems prior to and post-validation. Provide technical support to users of validated systems as required; critical thinking skills that result in creative solutions to complex problems are a must-have. Provide assistance to the engineering department in support of ongoing projects. Work under the direction of the Validation Manager or a designate and interact with all other departments for Engineering and Validation-related issues as required.
Specifically, the Validation Engineer III will perform the following duties:
• Conduct equipment qualification, specifically laboratory instrument qualification, which includes software validation;
• Develop and execute required protocols and complete reports for equipment, process utility, test, and software validations and revalidations as assigned;
• Develop and write Standard Operating Procedures, protocols, incidents, and final reports for new processes and equipment, in conjunction with the system owners;
• Support department projects by assisting the engineering department with ongoing projects;
• Assist in periodic review/requalification schedule compliance;
• Support internal and external audits by providing data appropriate to the investigation as required; and
• Keep Department Management and personnel aware of Engineering and Quality related issues that may have a regulatory compliance or financial impact.
REQUIREMENTS A Master’s degree in Engineering, Information Technology or a related technical field. 3 years of experience as a validation engineer, which includes 1 year of experience with the following:
• Developing validation master plans (VMP), standard operating procedures (SOPs), and validation protocols;
• Preparing reports for equipment and other technical documents, such as user requirements and test protocols;
• Participating in root cause analysis, remediation plans, gap analysis, and Corrective and Preventive Actions (CAPAs);
• Validation tools and processes, which include waterfall, validation life cycle, and V-Model;
• FDA regulations and Good Documentation Practices (GDP) related to the different stages of the validation life cycle.
OR
A Bachelor’s Degree in Engineering, Information Technology or a related technical field. 5 years of experience as a validation engineer, which includes 1 year of experience with the following:
• Developing validation master plans (VMP), standard operating procedures (SOPs), and validation protocols;
• Preparing reports for equipment and other technical documents, such as user requirements and test protocols;
• Participating in root cause analysis, remediation plans, gap analysis, and Corrective and Preventive Actions (CAPAs);
• Validation tools and processes, which include waterfall, validation life cycle, and V-Model;
• FDA regulations and Good Documentation Practices (GDP) related to the different stages of the validation life cycle.
RATE OF PAY: $130,582/year - $140,000/year
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. CURIA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.