CSV Analytical and Enterprise Validation Specialist Job at Katalyst Healthcares & Life Sciences, Portsmouth, NH

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  • Katalyst Healthcares & Life Sciences
  • Portsmouth, NH

Job Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description



Job Description

:
We are looking for a Validation Specialist IV who will lead validation and compliance activities for computerized systems, analytical instruments, and enterprise software. This includes supporting system implementation, upgrades, administration, and retirement, while ensuring compliance with regulations and internal procedures. The role works closely with Manufacturing, Quality, Engineering, and IT teams.
Responsibilities:

  • Lead validation efforts for new and existing systems.
  • Act as the Subject Matter Expert (SME) for CSV, analytical, and enterprise systems.
  • Review and approve qualification documents (IQ/OQ/PQ).
  • Prepare user requirements and system configuration documents.
  • Support data integrity assessments and audit trail reviews.
  • Oversee equipment procurement and ensure proper installation and qualification.
  • Perform system administration tasks (user setup, backups, troubleshooting).
  • Write and update SOPs for system use and maintenance.
  • Participate in risk assessments and change controls.
  • compliance with 21 CFR Part 11, GAMP 5, and other regulatory guidelines.

Requirements:

  • Bachelor's degree in science or engineering field.
  • 5–10 years of work in validation, preferably in a pharma or biotech environment.
  • Good understanding of CSV, data integrity, and GMP regulations.
  • Experience with lab instruments and enterprise systems (like LIMS, CDS, ERP).
  • Strong documentation and technical writing skills.
  • Ability to troubleshoot and solve system-related issues.
  • Comfortable working with different departments and vendors.

Additional Information



All your information will be kept confidential according to EEO guidelines.

Job Tags

Contract work, Immediate start,

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