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Entegee, Inc.

Validation Engineer

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Based on Massachusetts data

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What they do

A Validation Engineer evaluates and maintains machinery and equipment used in manufacturing, and supervises workers that use and repair the machines.

$95,280 / year median in Massachusetts

-1% projected decline

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Job Description

Validation Engineer responsible for validating water utility and distribution systems, executing
IQ/OQ/PQ
activities, and maintaining validation documentation within a regulated manufacturing environment. Job Requirements Bachelor's degree in Engineering, Science, or a related technical discipline 1-5 years of validation experience within a regulated environment Experience with water distribution systems or water utility systems required Experience developing validation plans, protocols, and reports Experience executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Experience with equipment, utility, or process validation Knowledge of FDA requirements related to validation Knowledge of ISO standards related to validation Knowledge of Good Manufacturing Practices (GMP) Experience investigating deviations and supporting corrective and preventive actions (CAPA) Experience managing validation lifecycle documentation Experience working within industrial, manufacturing, or production utility environments Preferred Skills Validation experience within medical device, pharmaceutical, or biotechnology manufacturing Experience validating purified water or process water systems Experience with water purification processes Experience with distillation processes Experience with industrial utility systems Experience with commissioning and qualification of water systems Experience supporting regulated manufacturing facilities rather than laboratory or R D environments Job Responsibilities Develop and execute validation plans for water utility and distribution systems Develop, execute, and maintain validation protocols and reports Perform IQ, OQ, and PQ activities for water systems and associated equipment Validate water purification, distribution, and utility processes Ensure validation activities comply with applicable FDA, ISO, GMP, and internal requirements Maintain validation lifecycle documentation Investigate validation deviations and document findings Develop and implement corrective and preventive actions related to validation issues Support qualification and validation of utility equipment and processes Coordinate validation activities with Quality Assurance, Engineering, Manufacturing, and Regulatory functions Review validation data and document system performance against approved requirements Maintain validation records in accordance with applicable regulatory and quality system requirements
Pay:
45-50/hr 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.
Pay Details:
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for
Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.