Engineer, Drug Product – Filling, Washers, Autoclaves (JP13326)
About The Position
Our ideal candidate will have: Bachelor’s degree with 2 years of experience in drug product manufacturing (PhD would be overqualified). Previous experience in pharma or biotech industry with filling equipment. GMP experience. Experience with filling equipment, washers, and autoclaves desired. Must have equipment trouble shooting & continuous on-going plant support experience. The Engineer will be joining the Facilities & Engineering (F&E) group within Manufacturing, and Clinical supply organization at client. The group’s mission is to enable the introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably.
Requirements
- GMP Experience
- Troubleshooting
- Engineering
- Bachelor’s degree with 2 years of experience in drug product manufacturing (PhD would be overqualified).
- Previous experience in pharma or biotech industry with filling equipment.
- GMP experience.
- Must have equipment trouble shooting & continuous on-going plant support experience.
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Nice To Haves
- Experience with filling equipment, washers, and autoclaves desired.
Responsibilities
- Provide system ownership for Biopharmaceutical process and analytical equipment.
- Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
- Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order.
- Ensure necessary commissioning and qualification of systems is completed and interact with inspectors as necessary.
- Monitor systems to identify performance risks and implement risk reduction strategies.
- Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
- Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
- Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations
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What This Job Offers
Career Level
Mid Level
