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Commissioning, Qualification, Validation Engineer I

2 months ago

Houston, Texas, United States PSC Biotech Full time
Job Overview

PSC Biotech is seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team. As a CQV Engineer, you will play a critical role in ensuring the quality and compliance of our products and services.

Key Responsibilities
  • Develop and execute commissioning, qualification, and validation protocols for a range of equipment and systems.
  • Draft, review, author, and deploy all required validation documentation, including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, URS, FRS, and so on.
  • Provide technical support throughout the validation lifecycle, including risk assessment, deviation investigation, and change control activities.
  • Support environmental monitoring tasks as required.
  • 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 all project timelines and deliverables and drive successful validation of critical systems and equipment.
  • Contribute to the continuous improvement of validation processes and procedures.
  • Ensure compliance with industry regulations and requirements at all times.
Requirements
  • Bachelor's degree in a related engineering discipline.
  • 1-3 years of experience executing commissioning, qualification, and validation for a range of equipment within the pharmaceutical and/or medical device industries.
  • Knowledge of regulatory requirements (cGMP, FDA, etc.).
  • Excellent problem-solving, analytical, and technical skills.
  • Ability to problem-solve and troubleshoot effectively.
  • 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.
Benefits
  • Medical, dental, and vision insurance - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents.
  • Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability, and more.
  • 401(k) and 401(k) matching.
  • PTO, Sick Time, and Paid Holiday.
  • Education Assistance.
  • Pet Insurance.
  • Discounted rate at Anytime Fitness or 24-Hour Fitness.
  • Financial Perks and Discounts.
Equal Opportunity Employment Statement

PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state, and local laws concerning employment discrimination. Accordingly, the Company prohibits 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.