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CSV Lead

Partner Company
Spain

  • Lead CSV and compliance for capital projects involving computerized manufacturing and lab systems.
  • Plan, execute, and approve validation lifecycle documentation per GxP and regulatory expectations.
  • Provide expert guidance on risk-based validation, IQ/OQ/PQ, change control, CAPA, and data integrity.

GxP Risk Management Stakeholder Management
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Lead Computer System Validation Engineer

Praxis Precision Medicines
$150,000–$178,000/yr
US

  • Lead and scale the Computer System Validation capability across IT, defining validation strategy, operating model, and risk-based approach while building the CSV team.
  • Author, review, and execute validation lifecycle deliverables including validation plans, requirements, risk assessments, and test protocols.
  • Collaborate with Quality, IT, business owners, and vendors to translate compliance needs into practical, scalable validation strategies.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. It is a lean and growing organization guided by core values of Trust, Ownership, Curiosity, and Results, with a commitment to diversity, equity, and inclusion.

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Digital Engineer – POMS MES

Unknown

  • Seeking a POMS MES Techno-Functional Subject Matter Expert for pharmaceutical manufacturing (GxP).
  • Responsible for bridging business, quality, validation, and IT to configure and support MES solutions.
  • Ensures compliance and operational excellence while leveraging strong MES, EBR, and GMP experience.

The company is a staffing firm that places digital engineers in the pharmaceutical industry. It focuses on contract roles for MES and compliance projects.

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