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Manager Validation and Facilities Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2422712 |
| Location: Swiftwater, Pennsylvania |
Date Posted: 8/6/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 7145871 |
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Job Description:
Responsibilities include troubleshooting utilities and production equipment, provide technical support for operation of utilities and equipment, maintenance of the validation status of the facility, and support quality initiatives through incident investigations and compliance audits. This position will work closely with the Formulation and Filling Manager, the on-site Maintenance group, Metrology, and Validation groups, as well as contractors hired to work within the facility.Specifically this position will develop, implement, and operate a daily management protocol for the operation of the facility. Troubleshoot utilities and production equipment to include Autoclaves, temperature-controlled storage units, vial and syringe filling machines, and a lyophilizer. Along with the Formulation and Filling Manager, troubleshoot process, utilities, and filling/lyophilization equipment. Prepare justification supplements for facility and equipment upgrades, renovations and changes.Provide innovative and timely solutions to facilities and equipment failures. This will involve multiple levels of interaction with the Formulation and Filling Manager, Maintenance, equipment manufacturer, Metrology, and outside contractors. Serve as the facilitator and leader for all these groups during their involvement in the pilot plant.Provide validation support to the Filling and Formulation Manager, Label and Packaging Manager, Metrology, outside contractors, etc. in order to achieve and maintain a constant state of readiness for cGMP operation of the facility.Write and revise documentation, including SOPs/SWIs and validation documentation for all facility and process equipment. Write and assist with incident investigations, CAPAs, and change controls associated with the facility and process equipment.
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For further information, please visit us online at http://www.pharmaceuticalcrossing.com
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: PharmaceuticalCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: |
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Web Site: http://www.pharmaceuticalcrossing.com
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