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Katalyst HealthCares & Life Sciences
Validation SpecialistKatalyst HealthCares & Life Sciences • Albany, NY
Validation Specialist

Validation Specialist

Katalyst HealthCares & Life Sciences • Albany, NY
30+ days ago
Job type
  • Full-time
Job description

Job Description:
  • We are seeking an experienced Validation Specialist to support validation activities for Syringe Assembly Machines (SAM) in a GMP-compliant pharmaceutical environment. The ideal candidate will possess a strong understanding of the validation lifecycle and documentation required to ensure compliance with industry standards and regulations.
Key Responsibilities:
  • Perform validation activities for Syringe Assembly Machines, including installation, operational, and performance qualification (IQ, OQ, PQ).
  • Develop, review, and execute validation protocols and reports in compliance with GMP standards.
  • Troubleshoot and resolve equipment-related issues during validation activities.
  • Collaborate with cross-functional teams, including Engineering, Quality Assurance, and Manufacturing, to ensure successful validation.
  • Maintain detailed and accurate documentation in accordance with regulatory requirements.
  • Support continuous improvement initiatives to optimize equipment performance and compliance.
Qualifications:
  • Minimum of years' experience in the validation of Syringe Assembly Machines or equivalent equipment in a GMP pharmaceutical environment.
  • Solid understanding of Validation Life Cycle documentation, including risk assessments, protocols, and reports.
  • Familiarity with regulatory standards such as FDA, EU GMP, and ISO guidelines.
  • Strong analytical, problem-solving, and communication skills.
  • Ability to work independently and as part of a team to meet project deadlines.
Preferred Qualifications:
  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • Experience with automated manufacturing equipment in sterile environments.
  • Compensation: Competitive hourly rate based on experience.

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Validation Specialist • Albany, NY

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