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Software Validation Specialist

2 months ago


Canton, Ohio, United States Beacon Hill Life Sciences - Boston Full time
Job Overview

Position Summary: We are looking for a seasoned Software Validation Specialist with a minimum of 5 years of practical experience in laboratory and analytical software. The ideal candidate will have a comprehensive grasp of software validation techniques and practices, particularly in ensuring adherence to compliance standards in regulated settings.

Primary Responsibilities:

  1. Validation Activities: Carry out validation tasks for laboratory and analytical software systems, guaranteeing compliance with regulatory frameworks such as FDA, EU GMP, and other pertinent standards.
  2. Documentation Management: Create and sustain validation documentation, including validation strategies, protocols, testing scripts, and summary reports, in accordance with company SOPs and regulatory requirements.
  3. Risk Assessment: Perform risk evaluations to identify and address potential software validation risks, ensuring the reliability of data produced by laboratory and analytical instruments.
  4. Change Management: Oversee change management processes related to software validation tasks, ensuring that modifications are executed in a controlled and documented manner.
  5. Collaboration: Work closely with cross-functional teams, including Quality Assurance, IT, Engineering, and Operations, to ensure that validation efforts align with broader business goals.
  6. Temperature Control Systems: Focus specifically on the validation of software systems linked to controlled temperature units, ensuring the precision and dependability of temperature monitoring and control.

Qualifications:

  • At least 5 years of experience in software validation within regulated sectors, emphasizing laboratory and analytical equipment and software.
  • Thorough understanding of regulatory standards such as FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
  • Familiarity with validation tools and methodologies, including IQ/OQ/PQ, CSV risk assessments, and traceability matrices.
  • Strong knowledge of controlled temperature units and their software system integration.
  • Exceptional communication and interpersonal abilities, with a proven track record of effective collaboration with cross-functional teams.