Enfield, United States
7 months ago
Lighthouse Professional Services, a division of Staffing 360 Solutions group of companies, has been providing contract and direct hire talent to client companies, ranging from small businesses to Fortune 500 corporations for over 50 years. Our offices are in New York, Connecticut, and Massachusetts, and we work with clients across the country. Our management and recruiting teams are led by experienced industry professionals. We invest in excellent working partnerships, powered by people.
Lighthouse Professional Services committed to the success of the companies, candidates and employees we serve. We invest in excellent working partnerships, powered by people.
We are currently seeking a Quality Engineer Validation in Enfield, CT.
Position Summary and Special Duties:
As a (an) your day to day duties will consist of and may not be limited to:
- Prepares protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems.
- Design on risk-based approach, review, and execute validation activities such as IQ, OQ, PQ for equipment, production processes, facilities, and other processes as needed, and generate reports which summarize results, specifications and its following acceptance criteria; this can cover the following areas:
- Equipment validation
- Process validation
- Clean room validation
- Test method validation
- Sterilization / related packaging validation
- Computer Software Validation (CSV)
- Consults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards.
- Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
- Collaborates and coordinates with appropriate departments and staff regarding the roles, scheduling, and/or implementation of validation testing.
- Identifies root causes of production problems.
- Identifies nonconformities of product or process standard and offers recommendations for resolving deviations.
- Develops and maintains databases for tracking test results, validation activities, or validated systems.
- Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices.
- Modifies testing methods or revisits test objectives and standards to resolve testing problems.
- Performs other related duties as assigned.
- Bachelor's degree from a four-year college or university in life sciences, or engineering. Several years related outside sales experience, preferable in bioprocess scientific equipment sales; or equivalent combination of education and experience.
- Valid driver’s license required. Must maintain a good driving record. Good credit standing and credit card to pay business travel expenses.
Some clients require proof that temporary associates have received all required doses of the COVID-19 vaccine by their first date of employment, unless a reasonable accommodation recognized by law is approved. To request an accommodation, please email email@example.com.
- Duration: Direct Hire
- Location: Enfield, CT
- Salary: Depending on experience
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume and salary expectations and any references.