Senior Validation Specialist

5 days ago


San Francisco, California, United States SciPro Full time
Senior Validation Engineer

At SciPro, we are seeking a highly skilled Senior Validation Engineer to join our team. As a key member of our validation team, you will be responsible for ensuring the quality and integrity of our products.

Key Responsibilities:

  • Develop and execute comprehensive validation plans to ensure compliance with regulatory requirements.
  • Lead cross-functional teams to conduct qualification and validation activities, including commissioning, performance qualification, cleaning validation, process validation, and revalidation.
  • Prepare and review validation documentation, including protocols, change controls, and summary reports.
  • Collaborate with internal stakeholders to identify and mitigate risks associated with validation activities.
  • Contribute to the development of manufacturing documents and procedures to ensure compliance with cGMP regulations.
  • Provide technical expertise and guidance to junior team members to ensure successful validation outcomes.

Qualifications / Requirements:

  • Bachelor's or Master's degree in Chemical or Biochemical Engineering, or a related field, with a minimum of 8 years (BS) or 6 years (MS) of experience in drug product process R&D, Engineering, Manufacturing, or Technical Services.
  • Proven experience in the pharmaceutical/biotech industry, with expertise in cleaning and sterilization validation.
  • Strong project management skills and ability to collaborate effectively with internal teams and external partners.
  • Excellent communication and technical writing skills, with the ability to prepare and review complex validation documentation.
  • Knowledge of cGMP regulations and industry standards, with the ability to apply this knowledge to ensure compliance.


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