Validation Engineer

Job Description:
We are seeking a skilled and detail-oriented Validation Engineer to join our team. The Validation Engineer will be responsible for ensuring that our processes, systems, and equipment meet regulatory standards and industry guidelines. The ideal candidate will have a strong background in validation principles, technical expertise, and a commitment to quality assurance.

Key Responsibilities:

  • Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, and processes in accordance with regulatory requirements and company standards.
  • Perform risk assessments and impact analyses to determine validation requirements and priorities.
  • Generate validation reports summarizing test results, deviations, and conclusions.
  • Collaborate with cross-functional teams including Quality Assurance, Engineering, and Production to coordinate validation activities and ensure compliance with regulatory standards.
  • Execute validation testing and inspections of equipment and systems to ensure functionality, reliability, and performance.
  • Review and approve validation documentation, including protocols, reports, and change controls.
  • Provide technical support and guidance to project teams on validation requirements and procedures.
  • Maintain validation schedules and records to ensure accuracy and completeness.
  • Stay updated on industry trends, regulatory changes, and best practices related to validation and quality assurance.

Qualifications:

  • Bachelor’s degree in Engineering, Pharmaceutical Sciences, or a related field. Advanced degree preferred.
  • Proven experience (X years) as a Validation Engineer or in a similar role, preferably in [industry sector].
  • Strong knowledge of validation principles, practices, and regulatory requirements (e.g., FDA, EU GMP).
  • Experience with validation protocols (IQ, OQ, PQ), risk assessment, and validation documentation.
  • Familiarity with equipment qualification and process validation in a manufacturing environment.
  • Excellent analytical and problem-solving skills with attention to detail.
  • Effective communication skills, both verbal and written.
  • Ability to work independently and collaboratively in a team environment.
  • Certification in validation or quality assurance (e.g., Certified Validation Professional) is a plus.

Benefits:

  • Competitive salary and comprehensive benefits package.
  • Opportunities for career growth and professional development.
  • Collaborative and inclusive work environment.
  • Access to cutting-edge technologies and resources to support validation activities.