Search Jobs: Results: Sr. Validation Engineer - MidWest (Focus on Pharmaceutical Process Validation Master Planning)
The Challenges:
1) Writing Validation Master Plans and remediation plans on product processes as well as with media filling and equipment such as tanks, mixers and pumps.
2) Leading multiple validation projects as well as internal and external technical transfers.
3) Being a SME and bringing others on your team up to speed on ASTM E2500 - 07 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment)
Salary: Base salary will be dependent on experience and could approach 80k. There will also be incentive compensation/bonus, benefits and relocation
Location: Mid West
Contact: Apply below and/or contact Ira Mann at iram@fpccareers.com
Additional Responsibilities:
• Provide validation input into system specification procurement and commissioning activities as well as ongoing validation and change control.
• Reviews and approves the validation sections of the NDA’s and ANDA’s.
• Supervise and train other validation personnel and provide project and technical direction.
• Determines appropriate scope and timing for remediation, review or revalidation of existing plant Equipment/Facilities/Utilities/Processes/Control Systems/Software.
• Responsible for reviewing and approving the final summary reports for qualification packages.
Requirements:
1) BS degree in Engineering or Science
2) ***MOST IMPORTANT *** is to present your experience with:
a. Validation Master Plans and remediation plans on product processes.
b. Subject matter expertise with ASTM E2500 - 07
3) 1 year of supervisory experience and/or Strong Project Management experience - especially with meeting deadlines
Preferences:
· 4+ years validation experience in a pharmaceutical drug product environment
· Process Validation expertise
· Media filling experience
· APS ( Aseptic Process Simulation) experience
· Equipment validation experience with tanks, mixers and pumps
· Experience in a multi-product facility as well as with leading technical transfers
Key Words: process validation, drug product, ASTM E2500-07, Project Management, Validation Master Plan, remediation, media fill, APS, aseptic process simulation, equipment validation, mixer, tank, pump, technical transfer, lean manufacturing, commissioning and qualification parenteral
Job Details
| Name: | Ira Mann | Date Posted: | 7/28/2010 |
| Office: | Atlanta | Telephone: | (770) 246-9757 |
| Email: | iram@fpccareers.com | Fax: | |
| Category: | Pharmaceutical, Validation | ||
| Keywords: | process validation, drug product, ASTM E2500-07, Project Management, Validation Master Plan, remediation, media fill, APS, aseptic process simulation, equipment validation, mixer, tank, pump, technical transfer, lean manufacturing, commissioning and qualification parenteral | Region: | Mid West (IA, KS, MN, MO, NE) |
| State: | City: | ||
| Education: | BS | Job Number: | J37451-ATLA-15270-IM |
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