Commissioning, Qualification, Validation Engineer

5 days ago


San Diego, California, United States PSC Biotech Full time
About PSC Biotech

PSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.

Our team of experts spans across the globe, with strategically located offices in North America, Europe, Asia, and the Middle East. We take pride in our ability to bring together the best and brightest professionals to form a truly exceptional team.

About the Role

We are seeking experienced CQV Engineers to support the commissioning, qualification, and validation of equipment and systems within the pharmaceutical and medical device industry.

As a CQV Engineer, you will be responsible for leading the development and execution of commissioning, qualification, and validation protocols for a range of equipment and systems. You will also be responsible for drafting, reviewing, and deploying all required validation documentation, including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, and more.

You will provide technical expertise throughout the validation lifecycle, including risk assessment, deviation investigation, and change control activities. You will also support environmental monitoring tasks as required and effectively identify potential risks and areas of improvement.

Key Responsibilities:

  • Lead the development and execution of commissioning, qualification, and validation protocols for equipment and systems.
  • Draft, review, and deploy all required validation documentation.
  • Provide technical expertise throughout the validation lifecycle.
  • Support environmental monitoring tasks as required.
  • Effectively identify potential risks and areas of improvement.
Requirements

To be successful in this role, you will need:

  • Bachelor's degree in a related engineering discipline.
  • 5 years or more of experience executing commissioning, qualification, and validation for equipment within the pharmaceutical and medical device industries.
  • Knowledge of regulatory requirements, including cGMP and FDA.
  • 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.
Benefits

PSC Biotech offers a comprehensive benefits package, including:

  • Medical, dental, and vision insurance.
  • 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 fitness rates.
  • Financial perks and discounts.

Estimated Annual Salary: $95,000 - $125,000.

PSC Biotech is an equal opportunity employer, 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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