Validation Engineer Entry Level

VALIDATION ASSOCIATES LLC; Columbus (GA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation package

Professional development and training

Collaborative work environment

Career growth opportunities

Job summary

Validation Associates LLC is seeking a Validation Engineer to lead equipment qualification, process validation, and cleaning validation efforts in the US. The role involves developing protocols, performing IQ/OQ/PQ, and ensuring compliance with FDA regulations and 21 CFR Part 11.

You will collaborate with cross-functional teams, document findings, and perform risk assessments while staying current with industry standards.

Qualifications

• Bachelor's or Master’s degree in Engineering, Life Sciences, or related field.
• Experience in validation activities within pharmaceutical or medical device industry.
• Familiarity with regulatory guidelines including FDA regulations and 21 CFR Part 11.
• Strong problem-solving and analytical skills.
• Knowledge of GMP, GDP, and quality systems.
• Proficiency in validation software and tools.
• Excellent communication and teamwork abilities.

Responsibilities

• Perform equipment qualification, process validation, and cleaning validation activities.
• Develop and execute validation protocols, including IQ/OQ/PQ.
• Conduct risk assessments, root cause analysis, and FMEA.
• Collaborate with cross-functional teams to ensure regulatory compliance.
• Maintain accurate documentation and reports related to validation activities.
• Stay updated on industry regulations and guidelines.

Skills

Problem solving

Analytical skills

Communication

Teamwork

Regulatory knowledge

Education

Bachelors or Masters in Engineering/Life Sciences

Tools

Validation software

Job description

Are you a talented Validation Engineer seeking new opportunities in the US?

Responsibilities

• Perform equipment qualification, process validation, and cleaning validation activities.
• Develop and execute validation protocols, including IQ/OQ/PQ.
• Conduct risk assessments, root cause analysis, and failure mode effects analysis (FMEA).
• Collaborate with cross-functional teams to ensure compliance with regulatory standards.
• Maintain accurate documentation and reports related to validation activities.
• Stay updated on industry regulations and guidelines.

Requirements

• Bachelors or Master's degree in Engineering, Life Sciences, or related field.
• Previous experience in validation activities within the pharmaceutical or medical device industry.
• Familiarity with regulatory guidelines, including FDA regulations and 21 CFR Part 11.
• Strong problem-solving and analytical skills.
• Knowledge of GMP, GDP, and quality systems.
• Proficiency in validation software and tools.
• Excellent communication and teamwork abilities.

Benefits

• Competitive compensation package.
• Exciting opportunities in the life sciences industry.
• Continuous professional development and training programs.
• Collaborative and supportive work environment.
• Career growth and advancement opportunities.