Equipment Validation Engineer

Entegee; Raynham (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

An established industry player is looking for a dedicated Validation Engineer to spearhead validation efforts for a critical distiller project. This role is vital for ensuring compliance with regulatory standards and maintaining quality excellence. You will develop and execute validation plans and protocols for various manufacturing equipment, collaborate with cross-functional teams, and manage documentation to meet internal and external standards. If you have a strong background in validation within regulated environments and a passion for quality assurance, this opportunity is perfect for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401K Plan

Commuter Benefits

Short-term Disability Insurance

Paid Sick Leave

Holiday Pay

Qualifications

• 3+ years of validation experience in regulated environments.
• Strong understanding of FDA, ISO, and GMP guidelines.

Responsibilities

• Develop and execute validation plans and protocols.
• Conduct IQ/OQ/PQ validations ensuring compliance.

Skills

Validation Experience

Problem-Solving Skills

Analytical Skills

Communication Skills

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Science

Tools

CNC Machines

3D Printers

Manufacturing Equipment

Job description

Direct message the job poster from Entegee

We are seeking a dedicated Validation Engineer to lead the validation efforts for a critical distiller project. This role is essential for ensuring compliance with regulatory standards, quality excellence, and robust validation practices within our facility.

Responsibilities:

• Develop and execute validation plans, protocols, and reports for the distiller system and equipment - CNC, 3D Printers, mills, lathes, manufacturing equipment

• Conduct IQ/OQ/PQ validations, ensuring compliance with policies and regulatory guidelines.

• Collaborate cross-functionally with Quality Assurance, Engineering, Manufacturing, and Regulatory Affairs teams.

• Investigate deviations and implement corrective and preventive actions.

• Manage documentation and validation lifecycle activities in accordance with internal and external regulatory standards.

Qualifications:

• Bachelor’s degree in Engineering, Science, or a related technical discipline.

• Minimum of 3 years of validation experience within a regulated environment, preferably in medical devices, pharmaceuticals, or biotechnology.

• Strong understanding of FDA, ISO, and GMP guidelines related to equipment and process validation.

• Experience with distillation or purification processes is highly desirable.

• Excellent problem-solving, analytical, and communication skills.

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Medical Equipment Manufacturing

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