What are the responsibilities and job description for the Validation Specialist position at Katalyst CRO?
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.
- 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.
- Minimum of 2 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.
- 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.