Job Description

Job Description

Job Title: Validation Engineer

Location: Lebanon, IN

Employment Type: Contract

Duration: 12 Months

Pay Range: $50-55/hr on W2 negotiable, based on experience

Job Summary

We are seeking a skilled Validation Engineer to support validation activities for manufacturing processes, equipment, systems, and products in a regulated environment. The ideal candidate will have experience developing and executing validation protocols, preparing technical documentation, conducting qualification activities, and ensuring compliance with applicable quality and regulatory standards.

Responsibilities

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• Develop, review, and execute validation protocols, plans, and reports for equipment, manufacturing processes, facilities, and systems.
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• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
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• Support process validation, equipment qualification, cleaning validation, and test method validation, as applicable.
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• Prepare and maintain validation documentation, including protocols, reports, risk assessments, and standard operating procedures (SOPs).
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• Ensure validation activities comply with applicable regulatory requirements, quality standards, and internal procedures.
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• Collaborate with Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs teams to support validation projects.
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• Investigate deviations, out-of-specification results, and validation failures; assist with root cause analysis and corrective and preventive actions (CAPA).
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• Support change control assessments and evaluate the impact of process, equipment, or system changes on validated states.
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• Participate in audits, inspections, and continuous improvement initiatives.
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• Maintain accurate documentation and ensure validation records are complete, traceable, and audit-ready.
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Required Qualifications

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• Bachelor's degree in Engineering, Life Sciences, Chemistry, Pharmacy, or a related technical field.
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• 3-6 years of experience in validation engineering, process validation, equipment qualification, or a related field.
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• Hands-on experience with IQ, OQ, and PQ protocols and execution.
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• Knowledge of validation lifecycle principles, risk assessment, deviation management, and change control.
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• Familiarity with Good Manufacturing Practices (GMP) and applicable quality management systems.
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• Strong technical writing, documentation, analytical, and problem-solving skills.
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• Ability to collaborate with cross-functional teams and manage multiple validation activities.
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Preferred Educational Background: Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, Chemical Engineering, Electrical Engineering, Life Sciences, or a related engineering or scientific discipline.

Preferred Qualifications

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• Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
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• Familiarity with FDA regulations, Health Canada requirements, ISO standards, and applicable GMP guidelines.
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• Experience with process validation, equipment qualification, cleaning validation, or computerized system validation.
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• Knowledge of CAPA, root cause analysis, FMEA, and continuous improvement methodologies.
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• Experience supporting internal and external audits or regulatory inspections.
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Work Requirements

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• Must be able to work at the designated client site in Canada, as required.
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• Must be legally authorized to work in Canada for the duration of employment.
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• Ability to prepare technical documentation and support on-site validation execution.
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• Occasional travel or extended hours may be required depending on project needs.
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Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws

Equal Employment Opportunity (EEO)

We are an equal opportunity employer and consider qualified applicants without discrimination based on any legally protected status under applicable Canadian employment and human rights legislation.

Application

Interested candidates are encouraged to submit their updated resume highlighting relevant validation engineering experience, technical skills, and availability.

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