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Process Equipment Specialist
1 week ago
This Facilities Engineer position is a key member of our Insight Global team. You will collaborate with the corporate engineering team to design, build, commission, and qualify new equipment and systems for drug substance production.
Key Accountabilities- Develop and implement system improvements, ensuring compliance with GMP requirements.
- Collaborate with the engineering team to design and install new equipment and systems.
- Conduct risk assessments to identify potential issues and develop mitigation strategies.
- Implement equipment maintenance programs, ensuring spare parts availability and optimal system functionality.
- Interact with regulatory inspectors during qualification and commissioning processes.
- Pursue initiatives to reduce production downtime through technical root cause analysis and corrective/preventive action implementation.
- Support new product introductions by conducting engineering assessments and implementing equipment modifications.
- Bachelor's Degree in Engineering or related field.
- 6+ years of experience in Process/Facilities Engineering.
- 5+ years of experience in a pharmaceutical or biopharmaceutical manufacturing environment.
- Knowledge of GMP Biopharmaceutical Production facility equipment/systems.
- Analytical skills and experience with data-driven techniques.
- Familiarity with regulated environments and quality systems/processes.
- Experience applying engineering principles to system modifications and capital project oversight.
- Domestic/international travel ability.
A successful candidate will have a strong foundation in engineering principles and excellent communication skills.