CQV Engineer - Intellectt INC
Boston, ME
About the Job
Key Responsibilities:
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Qualification and Validation:
- Perform qualification and process engineering tasks, ensuring the integrity and reliability of processes.
- Conduct validation activities for fill finish lines, isolators, and autoclaves.
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Protocol Development:
- Develop and execute validation protocols and comprehensive reports to document findings and compliance.
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Regulatory Compliance:
- Ensure all activities comply with GMP and relevant regulatory standards.
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Collaboration:
- Work collaboratively with cross-functional teams to support project goals and deliverables.
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Problem Solving:
- Address and resolve any validation-related issues that arise during the process.
Qualifications:
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Experience:
- 4-5 years of experience in process validation engineering with hands-on experience in fill finish lines.
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Technical Knowledge:
- Strong understanding of CQV principles and practices, with extensive GMP experience.
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Skills:
- Excellent problem-solving abilities and a self-starter attitude.
- Ability to work independently and as part of a collaborative team.
Source : Intellectt INC