Commissioning, Qualification, Validation Specialist

4 weeks ago


Irvine, California, United States PSC Biotech Full time
About the Role

PSC Biotech is seeking an experienced CQV Engineer to support the commissioning, qualification, and validation of equipment within the pharmaceutical and/or biotechnology industry.

The ideal candidate will have a strong background in commissioning, qualification, and validation, with experience in steam generator systems. They will be responsible for leading the development and execution of commissioning, qualification, and validation protocols for plant equipment, as well as drafting and reviewing validation documentation.

Key Responsibilities
  • Lead the development and execution of commissioning, qualification, and validation protocols for plant equipment.
  • Draft, review, and author validation documentation, including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, and reports.
  • Provide technical expertise throughout the validation lifecycle, including risk assessment, deviation investigation, and change control activities.
  • Effectively identify potential risks and areas of improvement and proactively implement risk mitigation.
  • Document test results, deviations, and investigations in compliance with company procedures and regulatory standards.
  • Collaborate with cross-functional teams to support project timelines and deliverables.
  • Contribute to the continuous improvement of validation processes, procedures, and projects.
  • Manage projects from initiation to completion, ensuring compliance with regulatory requirements and company standards.
Requirements
  • Bachelor's degree in a related engineering discipline.
  • 3+ years of experience executing commissioning, qualification, and validation for plant utilities equipment within the pharmaceutical and/or biotechnology industries.
  • Knowledge of regulatory requirements, including cGMP and FDA.
  • Project Management experience or certification preferred.
  • 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.
What We Offer
  • Competitive salary range: $100,000 - $120,000 annually.
  • Medical, dental, and vision insurance.
  • 401(k) and 401(k) matching.
  • PTO, sick time, and paid holiday.
  • Education assistance.
  • Pet insurance.
  • Discounted fitness/gym rates.
  • Financial perks and discounts.

PSC Biotech is an equal opportunity employer and is committed to a policy of equal employment opportunity with respect to all employees, interns, and applicants for employment.



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