|
Job ID:
|
4559105
|
|
Position Title:
|
Sr. Validation Specialist
|
|
Company Name:
|
Bayer Animal Health
|
|
Industry:
|
Traditional Pharmaceuticals
|
|
Job Function:
|
Validation/Qualification/Commissioning
|
|
Entry Level:
|
No
|
|
Location(s):
|
Shawnee, Kansas, 66203,
United
States
|
|
|
Posted:
|
June 25, 2008
|
|
Job Type:
|
Full-Time
|
|
Job Duration:
|
Indefinite
|
|
Min Education:
|
BA/BS/Undergraduate
|
|
Min Experience:
|
5-7 Years
|
|
Required Travel:
|
0-10%
|
|
Job Description
Bayer Animal Health is a world leading innovation-driven
veterinary pharmaceutical company, providing a comprehensive range of products
to enhance the health, well-being and performance of a wide range of animals.
Bayer Animal Health operates in more than 100 countries worldwide and is wholly
part of Bayer Group internationally.
Bayer is seeking an individual to perform the following duties:
The Sr. Validation specialist performs or oversees the validation of
facilities, equipment, and processes. The validation specialist reviews
specifications, drawings, inspects installations, checks system operations,
conducts or coordinates performance testing, and writes, reviews and approves
validation documents (protocols, reports, etc.) The Validation specialist
approves standard operating procedures for routine validation activities. The
validation specialist is involved in validation monitoring activities which
include audits with the system owner, review of operational documents. Directs
and supervises the activities and provides guidance to contract specialists
when needed.
1. Active member in site validation activities. Works with
outside contractors, Engineers, Laboratories and QA.
2. Writes, reviews and approves validation documents for selected
projects, manages and maintains schedule of validation activities.
3. Supervises validation activities and contractors for selected projects.
4. Writes, reviews and approves validation documents. Ensures documents are
signed off in a timely manner.
5. Writes standard operating procedures describing validation principles and
activities.
6. Actively participates during all phases of validation: evaluates projects,
provides guidance and technical information to others. Supports IQ activities
in Engineering, checks operating parameters during OQ, and coordinates with
testing participants (QA, Production) during PQ, PV and CV activities.
7. Reviews engineering drawings (P&IDs, construction, as-built, flow
diagrams) for compliance to GMP/Validation principles.
8. Performs and reviews validation testing as required.
9. Reviews validation packets for completeness and accuracy, sound rationale,
compliance with validation policies and procedures, and accurate data analysis.
Compares results against acceptance criteria and bring exceptions and
deviations to management's attention. Recommends to management as to the
acceptance and release of qualified systems.
10. Establishes priorities, equipment, and schedule activities.
11. Coordinates activities with laboratories, provides team leadership and
assumes responsibility for entire project management.
BS degree in natural or physical science or engineering
plus 6 years experience in pharmaceutical engineering, manufacturing or quality
assurance or equivalent combination of education and
experience.
Expertise in the principles of design and validation of at least 2 of the
following:
Facilities (including design, flow analysis, HVAC/HEPA, pest control),
utilities)
Utilities (including WFI & purified water, steam compressed air and gasses,
process waste systems), major equipment, process validation
Process Validation
Equipment Qualification (cell culture, purification, filtration CIP, aseptic processing,
packaging)
Cleaning Validation
Computer/Automation Validation
Excellent company benefits package. Qualified candidates should apply at http://www.bayerjobs.com/, Animal Health,
Job #08-011.
BAYER ANIMAL HEALTH is an Equal Opportunity Employer;
M/F/Disabled/Vet. Bayer is committed to enhancing and maintaining cultural
diversity within our work environment.
http://www.jobtarget.com/c/job.cfm?site_id=465&jb=4559105&CFID=6526616&CFTOKEN=46d3f0e4bb099d61-576441C6-9A4A-5E6B-DA98F2C5443AEA38&jsessionid=d830297f55e153196a63
*Disclaimer: ASQ 1301 shall not be liable for the content or any errors or omissions in the information provided. Conclusions drawn from such information are the responsibility of the user.
Tracking code: 080626n
- Return to main Jobs page -
|
