Search Jobs: Results: Process Validation Supervisor - Aseptic Pharmaceutical, Sterile Media Filling and Lyophilization
Process Validation Supervisor sought for an expanding state of the art pharmaceutical manufacturing facility at one of the fastest growing sterile pharmaceutical companies in the world. Actually, multiple new opportunities have been created for process validation experts; media fill experts, cleaning experts, sterilization experts and even quality leaders.
Challenges:
This Process Validation Supervisor will be faced with the challenges of:
1) Supervising a growing team and being a subject matter expert on process validation, CIP and cleaning, Media Fills, Sterilization and environmental controls. Equipment you will also be involved with includes; Utilities and Facilities/HVAC systems including critical systems such as lyophilizers, ovens, autoclaves and water systems
2) Perform DOE studies and evaluate the ranges of critical process parameters so as to confirm their robustness.
3) Interfaces with customer leads to co-develop or transfer technical processes and provide rationales or validation studies to support acceptability of the manufacture of contract products
4) Provides Production Department with troubleshooting assistance concerning manufacturing anomalies or deviations where product impact may be an issue.
Salary: Base salary should be in the 70’s to the low 90's - depending on experience – and also will include a strong bonus and relocation package.
Location: Ohio
Contact: Apply below and/or contact Ira Mann at iram@fpccareers.com
You also will be challenged with:
- Determining how new technologies may be applied to increase process efficiency and implement.
- Evaluate the existing validation processes, compile relevant data packs, address deviations and recommend and implement corrective actions
- Lead validation efforts with both internal and contract validation groups and empower such groups to understand both what changes are needed and why.
- Reviewing or approving technical reports, validation test protocols and final reports; ensuring compliance with protocol test procedures and specifications; evaluating deviations which occur during the validation test process.
Requirements:
1. While a BS degree and 3+ years of relevant Aseptic Pharmaceutical process validation experience in required, IT IS MORE IMPORTANT THAT YOU SHOW YOUR EXPERIENCE WITH Supervision and Development of Process Validation practices and protocols
2. Experience with Media Filling, Cleaning Validation, Critical Systems, and Sterilization Validation.
3. Providing technical assistance via rationales or validation studies to support manufacturability.
4. PQ expertise
Preferences:
1. LYOPHILIZATION
2. Preference for BS degree to be in Scientific or Engineering field
Keyword (s): process validation, CIP, media fill, technology transfer, cleaning validation, investigations, deviations, DOE, critical process parameters, contract manufacturing, Lyophilization, critical systems, HVAC, WFI, water systems, autoclaves, lyophilizers, utilities, computerized systems validation, dry heat, sterilization, protocols, SOP’s
Job Details
| Name: | Ira Mann | Date Posted: | 7/07/2010 |
| Office: | Atlanta | Telephone: | (770) 246-9757 |
| Email: | iram@fpccareers.com | Fax: | |
| Category: | Contract Manufacturing, Pharmaceutical, Validation | ||
| Keywords: | process validation, CIP, media fill, technology transfer, cleaning validation, investigations, deviations, DOE, critical process parameters, contract manufacturing, Lyophilization, critical systems, HVAC, WFI, water systems, autoclaves, lyophilizers, utilities, computerized systems validation, dry heat, sterilization, protocols, SOP?s | Region: | |
| State: | OH | City: | |
| Education: | BS | Job Number: | J61310-ATLA-15140-IM |
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