Company:
Medix™
Location: Rensselaer
Closing Date: 26/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Key Responsibilities:
- Validation & Qualification : Perform and support IQ/OQ for new fill-finish equipment and filling lines. Ensure that all equipment is installed and operating according to design specifications and regulatory standards.
- Commissioning Support : Assist with the commissioning of new equipment, ensuring all systems and equipment function properly before starting the qualification process.
- Documentation : Prepare, review, and maintain detailed validation protocols, reports, and documentation in alignment with Good Documentation Practices (GDP) and GMP regulations.
- Collaboration : Work closely with cross-functional teams, including engineering, quality, and operations, to ensure seamless integration and validation of new systems.
- Regulatory Compliance : Ensure that all validation activities meet GMP regulatory requirements, contributing to the safe and compliant operation of the facility.
- Troubleshooting : Identify and resolve issues that arise during the validation process, collaborating with the team to ensure all equipment operates within validated parameters.
Qualifications:
- Experience : 4-10 years of hands-on experience in equipment validation and qualification, with a strong focus on IQ and OQ. Experience with PQ is preferred but not mandatory.
- Industry Experience : Prior experience working in GMP-regulated environments is required, particularly in the pharmaceutical or biotech industries.
- Equipment Knowledge : Experience with fill-finish equipment and filling lines is essential. Prior experience qualifying other types of equipment is a plus.
- Commissioning Experience : Strong understanding of commissioning activities for new equipment and systems.
- Documentation Skills : Proficiency in Good Documentation Practices (GDP), ensuring all validation activities are properly recorded and compliant with regulatory standards.
- Problem-Solving : Ability to troubleshoot equipment and processes during the validation phase and effectively collaborate with technical teams to resolve issues.
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