Validation Specialist

1 month ago

Los Angeles, California, United States PSC Biotech Full time
About the Role

We are seeking a highly motivated and experienced Validation Engineer to join our team at PSC Biotech. As a key member of our team, you will be responsible for ensuring the commissioning, qualification, and validation of equipment and systems in our pharmaceutical manufacturing and biotech environments.

Key Responsibilities
  • Develop and execute validation protocols (IQ, OQ, PQ) for required equipment, processes, and systems.
  • Write, review, and/or author all required validation documentation, including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, and reports.
  • Collaborate with cross-functional teams to ensure validation activities are aligned with project timelines and regulatory requirements.
  • Conduct risk assessments and validation impact assessments, investigate and resolve validation-related issues and deviations, and analyze test results, data, and acceptance criteria to ensure accuracy.
Requirements
  • Bachelor's degree in a related engineering discipline.
  • 1-5 years of experience executing commissioning, qualification, and validation for a range of equipment and systems within the pharmaceutical and/or biotechnology industries.
  • Experienced writing and generating technical validation documentation, including IQ/OQ/PQ protocols, reports, procedures, etc.
  • Knowledge of regulatory requirements and industry standards (cGMP, FDA, etc.).
  • Strong understanding of risk-based validation approach.
  • Proactive and motivated with the ability to manage multiple tasks/projects.
  • Excellent problem-solving, analytical, and technical skills.
  • Strong time management and organizational abilities.
  • Effective communication and interpersonal skills.
  • Detail-oriented mindset with a commitment to maintaining high-quality standards.
  • Ability to work independently and as part of a team.
What We Offer
  • A competitive salary range of $85,000 - $115,000 annually.
  • A comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and education assistance.
  • A dynamic and supportive work environment with opportunities for growth and development.
Equal Opportunity Employment Statement

PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. We prohibit discrimination against qualified employees, interns, and applicants in all aspects of employment, including recruitment, interviewing, hiring, evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination, and employer-sponsored activities and programs.

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