Quality Assurance Engineer

2 weeks ago


Marquand, Missouri, 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.

Job Summary

We are seeking a highly skilled Validation Engineer to join our team. As a Validation Engineer, you will play a critical role in ensuring the successful execution of commissioning, qualification, and validation of laboratory equipment, facility systems, and utilities.

Key Responsibilities
  • Develop and execute commissioning, qualification, and validation protocols for laboratory equipment, facility systems, and utilities.
  • Prepare and review validation documentation, including protocols, reports, master plans, risk assessments, procedures, and reports.
  • Conduct hands-on testing and analysis during qualification and validation tasks.
  • Participate in risk assessments and impact assessments, and support troubleshooting and risk resolution.
  • Document test results, deviations, and investigations in compliance with company procedures and regulatory standards.
  • Perform temperature mapping studies for controlled environments, lab spaces, warehouses, CTUs, and assist with supporting testing, reporting, and improvement initiatives.
  • Collaborate with cross-functional teams to support project timelines and deliverables.
  • Contribute to the continuous improvement of validation processes and procedures.
  • Ensure compliance with industry regulations and requirements.
Requirements
  • Bachelor's degree in a related engineering discipline.
  • 2+ years of experience in a validation role, having executed CQV protocols for a range of laboratory equipment, facilities, and utilities.
  • Experience with temperature mapping procedures and activities.
  • Proficiency with paperless validation systems (ValGenesis, KNEAT, etc.).
  • Experience with controlled systems.
  • Strong understanding of regulatory requirements, including cGMP and FDA.
  • Strong analytical skills with the ability to problem-solve and troubleshoot effectively.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
  • Detail-oriented mindset with a commitment to maintaining high-quality standards.
Benefits
  • Medical, dental, and vision insurance, with 100% coverage for qualifying employees.
  • 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 holidays.
  • Education assistance.
  • Pet insurance.
  • Fitness benefits, including membership discounts and perks at qualifying gyms.
  • Financial perks and discounts.


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