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Validation Engineer |
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Gala Biotech, a Catalent Pharma Solutions Company, is a biotechnology company engaged in the production of
recombinant proteins in cell culture systems for pharmaceutical and biotechnology applications. We are seeking a high caliber individual to fill our Validation Engineer
position for our Middleton, Wisconsin facility. |
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OBJECTIVE: |
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The Operations Department is responsible for
materials management, which includes warehousing and control of material movement,
calibration and validation activities, and cGMP activities. cGMP manufacturing
includes cell banking, upstream (cell culture) and downstream (protein purification)
activities.
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RESPONSIBILITIES: |
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The Validation Engineer has the primary responsibility
for protocol development and execution of validation qualifications. Where applicable,
oversight of contractor validation may be necessary. The Validation Engineer will conduct
validation activities, based upon engineering specifications that include authoring and
editing protocols, executing validation protocols and writing reports. The Validation
Engineer will identify deviations from test plan and will work with functional groups
to resolve deviations. The Validation Engineer must be able to perform calibrations
and execute simple repair procedures.
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Perform all necessary activities to execute IQ,
OQ and PQ protocols in a timely manner. |
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Coordinate the collection of necessary documentation for the
development of validation protocols. |
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Execute various engineering studies and pre-validation testing
to ensure proper execution of validation plans. |
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Perform calibrations following Standard Operating Procedures. |
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Develop and write Standard Operating Procedures. |
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Coordinate efforts with various departments to determine
appropriate validation requirements |
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Generate conclusions based on the review and analysis of
pertinent test data. |
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Write validation protocols and reports. |
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Analyze problems utilizing linear logic and apply
solutions to achieve an acceptable resolution. |
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Make simple repairs and adjustments to equipment and instrumentation. |
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Other duties as assigned. |
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QUALIFICATIONS: |
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Have knowledge of GMP regulations,
specifically 21 CFR - parts 210 and 211 and ISO Standards. |
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Excellent english verbal and written communication skills
to present problems, solutions and ideas. |
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MS Word, Excel, Access, experience including revision control and tracking. |
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Ability to self-start and follow through with initiatives and tasks. |
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Excellent workload management and organization skills to reach deadlines and goal. |
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Knowledge of PLC programs and ladder logic a plus. |
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The ability to read/decipher schematics (engineering drawings). |
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Mechanical and electrical aptitude. |
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Familiar with NCSL best practices a plus. |
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Previous calibration experience preferred. |
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Must be able to lift 25 Kgs. |
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EDUCATION: |
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BS degree in scientific or engineering
fields or a minimum of 5 years of relevant experience in the pharmaceutical industry. |
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Special consideration will be made for two year degree
programs specializing in calibration or the biotech industry. |
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Previous calibration experience preferred. |
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APPLICATION PROCESS: |
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Join an exciting organization! If you would
like to apply for this position with Gala Biotech, please send your
cover letter, resume, and salary requirements by mail or email to:
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by mail: |
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Human Resources
Gala Biotech
PO Box 620160
Middleton, WI 53562
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by e-mail: |
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gala.hr@catalent.com |
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Gala Biotech is an Equal Opportunity Employer |
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We offer a competitive salary and benefits package
including comprehensive health, life and disability insurance, 401(k),
vacation and holidays.
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