Validation Specialist

2 weeks ago


Boston, Massachusetts, United States Vastek, Inc. Full time
Job DescriptionAt Vastek Inc, we are seeking a highly skilled Validation Engineer to join our team. As a key member of our validation program, you will be responsible for ensuring the effective implementation and maintenance of our validation processes. Your expertise will be instrumental in supporting the Validation Manager and tracking/reporting action plan status/completion as it relates to validation systems improvement efforts. You will be responsible for writing and executing project and system qualifications, validation, and re-qualifications/periodic reviews.Key Responsibilities
  • Develop and execute validation plans, qualification protocols, and compile and analyze data to ensure that systems are qualified in accordance with applicable regulatory agencies, clients, and client specifications/requirements.
  • Highly experienced with equipment and/or computer system validation, with a strong understanding of GMP compliance.
  • Able to assess deviations that affect validation with minimal assistance and work with minimal assistance on moderate Corrective Action Preventive Action (CAPA) that result from deviations, internal audits, protocol discrepancies, global quality audits, or regulatory inspections.
  • Experience with autoclaves and VHP systems, with a strong understanding of mechanical validation, computer system validation (CSV), change control, CAPAs/deviations, data integrity, and project management.
Requirements
  • 2+ Years Experience in validation and quality assurance.
  • Bachelor's Degree required, with a strong understanding of GMP compliance.
  • Need to have CSV computer system validation experience and previous experience with mechanical validation, computer system validation (CSV), change control, CAPAs/deviations, data integrity, and project management.


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