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Equipment Reliability Engineer
2 months ago
The Equipment Engineer plays a crucial role in ensuring the efficient functioning of laboratory and clinical manufacturing processes. This position requires collaboration with internal teams and external service providers to maintain operational excellence.
Key Responsibilities:
- Conduct equipment calibration, preventive maintenance, and performance verification in laboratory and manufacturing settings.
- Oversee vendor activities related to calibration and maintenance, ensuring compliance with established standards.
- Review and validate vendor documentation for accuracy and completeness.
- Manage requalification processes for Controlled Temperature Units, including refrigerators and freezers.
- Support multiple operational sites and contribute to deviations and investigations stemming from calibration activities.
- Develop and revise standard operating procedures for calibration and maintenance.
- Collaborate with the Planning group to maintain accurate records of calibration and maintenance activities.
Required Qualifications:
- In-depth knowledge of cGMP, GXP, GAMP, and SDLC regulations.
- Experience with pharmaceutical manufacturing and laboratory systems.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal abilities.
- Proficiency in Microsoft Office Suite and familiarity with inventory management systems.
Regulatory Compliance:
- Maintain all necessary training and adhere to safety protocols.
- Act as a Subject Matter Expert during internal and regulatory audits.
This position demands a proactive approach to equipment management and a commitment to maintaining high standards of quality and compliance.
