Search Jobs: Results: Media Fill Process Validation Supervisor - Aseptic Pharmaceutical
Media Fill and 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 Media Fill and Process Validation Supervisor will be faced with the challenges of:
1) Supervising a growing team and leading the validation of multiple lines in a large and diverse media filling facility.
2) Design media fill and APS systems and performing mixing studies
3) Leading the aseptic transfer of multiple products and assure the repeatability, consistency and reproducibility of aseptic simulations.
4) Assure the lines ability to process vials within proper control bands and potency
Salary: Base salary should be in the low 80’s to the 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 Media Fill validation experience in required, IT IS MORE IMPORTANT THAT YOU SHOW YOUR EXPERIENCE WITH:
- Supervising media fill validations and designing media fill and APS systems or protocols
2. Experience leading the aseptic transfer of multiple products and assure the repeatability, consistency and reproducibility of aseptic simulations.
3. Experience assuring the lines ability to process vials within proper control bands and potency
Keyword (s): process validation, media fill, technology transfer, APS, aseptic simulation, control band, potency, consistency, repeatability, mixing study, investigations, deviations, critical process parameters, contract manufacturing, Lyophilization, critical systems, lyophilizers, utilities, computerized systems validation, protocols, SOP’s
Job Details
| Name: | Ira Mann | Date Posted: | 6/11/2010 |
| Office: | Atlanta | Telephone: | (770) 246-9757 |
| Email: | iram@fpccareers.com | Fax: | |
| Category: | Biotechnology, Pharmaceutical, Validation | ||
| Keywords: | process validation, media fill, technology transfer, APS, aseptic simulation, control band, potency, consistency, repeatability, mixing study, investigations, deviations, critical process parameters, contract manufacturing, Lyophilization, critical systems, lyophilizers, utilities, computerized systems validation, protocols, SOP?s | Region: | |
| State: | OH | City: | Cleveland |
| Education: | BS | Job Number: | J47617-ATLA-15153-IM |
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