Equipment Validation Specialist

1 week ago


Cambridge, Massachusetts, United States Beacon Hill Full time

Company Overview:

Beacon Hill Life Sciences is actively seeking a skilled Validation Engineer to support critical projects in the biotechnology and pharmaceutical sectors.

Role Overview:

This position focuses on the validation of new laboratory equipment, ensuring compliance with industry standards and regulations. The successful candidate will possess an engineering degree and have a minimum of three years of relevant experience in validation processes.

Key Responsibilities:

  • Execute Installation Qualification (IQ) and Operational Qualification (OQ) for newly installed laboratory and manufacturing equipment.
  • Conduct dry runs to validate the functionality of new equipment.
  • Develop and revise Standard Operating Procedures (SOPs) and validation protocols.
  • Collaborate with the engineering team to meet project deadlines and objectives.

Qualifications:

  • A minimum of three years of experience in the biotech or pharmaceutical industry, specifically in equipment validation.
  • Extensive knowledge of laboratory development and GxP provider management.
  • Familiarity with drug research and development processes.
  • In-depth understanding of GxP regulations, including FDA, EU, ICH, and other relevant guidelines.

Core Competencies:

  • Good Clinical Practice (GCP)
  • Good Manufacturing Practice (GMP)
  • Good Laboratory Practice (GLP)
  • Experience with computerized systems and associated GxP requirements.

We encourage qualified candidates to submit their resumes for consideration. Thank you for your interest in this opportunity.



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