Job Title: Engineer Drug Product Filling Washers Autoclaves (JP13326 Location: Thousand Oaks CA. 91320 Business Unit: F&E Drug Product Supply Employment Type: Contract Duration: 1 year with likely extensions and/or conversion to a permanent position. Rate: $38 $42/hour W2 Posting Date:10/29/2024. Notes: Only qualified candidates need apply. No relocation candidates!
3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client a leading global biotechnology company.
Job Description: Our ideal candidate will have:
Bachelors 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 ongoing plant support experience.
The Engineer will be joining the Facilities & Engineering (F&E) group within Manufacturing and Clinical supply organization at client. The groups mission is to enable the introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably.
Top Must Have Skill Sets:
GMP Experience
Troubleshooting
Engineering
Day to Day Responsibilities:
Provide system ownership for Biopharmaceutical process and analytical equipment. Identify support and/or lead implementation of engineeringbased 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
Basic Qualifications:
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
Red Flags: Resumes with only validation experience but no engineering experience.
Interview Process: Initial phone screen by me. Panel interview of candidates pass the phone screen.
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