Equipment Validation Engineer Entegee - 3.7 Bridgewater, MA Job Details Contract $50 - $55 an hour 9 hours ago Benefits Commuter assistance Disability insurance Health insurance Dental insurance Vision insurance Life insurance Qualifications Quality control corrective actions Laboratory equipment performance testing and validation Technical documentation Preventive action implementation Production deviation management Quality control preventive actions Corrective and preventive actions (CAPA) GMP Technical support Manufacturing facility experience Production validation processes Medical device manufacturing facility experience Quality control documentation Biomedical regulatory compliance Test Execution (Quality assurance practices) Industrial equipment Equipment testing Investigating compliance violations Production documentation FDA regulations Engineering manufacturing support Full Job Description Equipment Validation Engineer Bridgewater MA area 6 mothns + contract

ID:

1647175 Validation Engineer responsible for equipment and process validation activities, including

IQ/OQ/PQ

execution, documentation, deviation investigation, and lifecycle support within a regulated medical device manufacturing environment. Job Requirements Bachelor's degree in Engineering, Science, or a related technical discipline. 2+ years of validation experience in a regulated manufacturing environment. Medical device industry experience. Hands-on manufacturing experience. Experience with equipment validation. Experience developing and executing validation plans, protocols, and reports. Experience performing IQ, OQ, and PQ activities. Knowledge of FDA requirements related to equipment and process validation. Knowledge of ISO requirements applicable to regulated manufacturing. Knowledge of GMP requirements. Experience investigating validation deviations. Experience supporting corrective and preventive action activities. Experience managing validation documentation and lifecycle records. Ability to perform hands-on validation activities alongside manufacturing technicians and assemblers. Preferred Skills Experience with distillation or purification equipment and processes. Experience validating manufacturing equipment used in medical device production. Experience with process validation. Experience supporting validation activities involving Engineering, Quality Assurance, Manufacturing, and Regulatory functions. Experience with deviation management and CAPA documentation. Experience supporting equipment qualification from installation through production release. Job Responsibilities Develop and execute equipment and process validation plans. Author and execute IQ, OQ, and PQ protocols. Prepare validation reports and supporting documentation. Perform hands-on validation activities on manufacturing equipment. Support validation of distillation or purification systems. Verify equipment performance against defined technical and regulatory requirements. Investigate validation deviations and document findings. Develop and support corrective and preventive actions related to validation issues. Maintain validation lifecycle documentation and equipment qualification records. Ensure validation activities comply with applicable FDA, ISO, GMP, and internal quality requirements. Coordinate validation activities with Quality Assurance, Engineering, Manufacturing, and Regulatory functions. Support manufacturing technicians and assemblers during equipment qualification and testing. Maintain traceability between validation requirements, test execution, deviations, and final reports. #

GRPA Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records.

Pay:

$50.00 - $55.00 per hour Application Question(s): 2+ years of validation experience in a regulated manufacturing environment Medical device industry experience Experience performing IQ, OQ, and PQ activities. Knowledge of FDA requirements related to equipment and process validation. Knowledge of ISO requirements applicable to regulated manufacturing.

Work Location:

In person