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Validation Engineer

Job in Belmont, Gaston County, North Carolina, 28012, USA
Listing for: Kasmo Global
Full Time position
Listed on 2026-07-01
Job specializations:
  • Engineering
    Validation Engineer, Pharma Engineer, Process Engineer, Quality Engineering
Job Description & How to Apply Below

Job Title

JCQV Engineers

Job Description

JCQV Engineers are responsible for supporting commissioning, qualification, and validation projects for pharmaceutical facilities, utilities, equipment, and systems. You will play a key role in executing CQV deliverables and ensuring operational readiness from the ground up to support our clients' success.

• Assist in commissioning and startup of new equipment, utilities, and cleanroom systems during facility buildout.

• Develop and execute IQ/OQ/PQ protocols for newly installed systems and equipment.

• Prepare and maintain documentation, including validation protocols, plans, reports, and standard operating procedures.

• Support risk assessments and mitigation strategies related to CQV activities.

• Troubleshoot and assist in resolving issues related to equipment and process performance.

• Collaborate with cross-functional teams to align CQV activities with construction and project timelines.

• Coordinate with vendors and contractors to support hand-offs and system turnover.

• Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).

• Provide technical support during validation execution and qualification activities.

• Additional responsibilities as required.

Requirements

• Bachelor's degree in engineering or a related field.

• 7-10 years of commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries.

• Proven experience supporting or leading CQV activities during new facility buildouts, including equipment installation and startup.

• Strong background in cleanroom facilities, process equipment, and utility systems.

• Familiarity with project execution and project management tools.

• Deep understanding of regulatory requirements and industry standards (GMP, GAMP, FDA, EMA).

• Knowledge of validation lifecycle and risk-based approaches.

• Excellent analytical and technical problem-solving skills.

• Strong technical writing skills and experience with validation documentation (protocols, reports, procedures, etc.).

Effective communication and interpersonal skills.

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