Senior Validation Engineer

4 days ago


San Diego Country Estates, 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 mission is to empower our clients' success by delivering exceptional services and expertise, leveraging a global team of skilled professionals and experts.

The Role

We are seeking an experienced Senior Validation Engineer to lead the commissioning, qualification, and validation of equipment and systems within the pharmaceutical and/or medical device industry.

  • Develop and execute commissioning, qualification, and validation protocols for a range of equipment and systems.
  • Draft, review, and deploy all required validation documentation, including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, URS, FRS, and more.
  • Provide technical expertise 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 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.
  • Additional responsibilities as required.
Requirements
  • Bachelor's degree in a related engineering discipline.
  • 7 years or more 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

PSC Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, PTO, sick time, and paid holidays, as well as education assistance, pet insurance, and discounted fitness rates.

We are committed to providing a supportive and inclusive work environment that fosters growth and development.



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