Validation Lead III
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Validation Lead III
Ref No.: 16-02385
Location: Swiftwater, Pennsylvania
Start Date / End Date: 09/13/2016 to 12/31/2016
Additional Information: Good Afternoon,
The following is feedback from the manager regarding the candidates reviewed and interviewed so far. She is looking to looking review additional candidates as soon as possible.
• Ideal candidate will have 5-10 years of validation experience. Many candidates reviewed have 15 years+ and have moved into more of a manager/supervisory role. They are s looking for a "doer” someone who understands the fast passed environment and workload.
• IQ, OQ, and PQ validation experience is not a good fit. Candidates must have Process, Fill and/or formulation validation experience. They also said mixing development could be useful and some experience with Technical Writing would be a plus.


Sanofi Pasteur has openings to support validation activities at our Swiftwater site. The Validation Specialist will be responsible for generating validation protocols and reports, compile data packs and analyze data for aspect of the processes such as hold time, formulation, filling, CCIT, shipping and Extractable/Leachables. In addition, small scale formulation and filling experience is desired.
Formulation and/or Filling Validation
Recent hands on experience executing qualifications or process validations
For filling, significant experience from production or engineering assignments to have in-depth knowledge of vial and/or syringe filling equipment sufficient to identify process CPP's and generate detailed validation protocol requirements and execution
For formulation demonstrated experience with mixing and filtration process validation.
Hands on execution is required

Experience: 3 to 9 years. Experience in, Process Validation (formulation and/or filling), , Performance Qualification, E&L, CCIT, shipping validation and/or Filter Validation
Skills:Skills, MS Office 2010, E Doc, Pharmaceutical Validation, Bio Pharma Validation, Validation execution, Cleaning Validation
Technical writing abilities and good time management. Strong root cause analysis skills with cGMP experience. To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required. Troubleshooting abilities desired.
Must be proficient in E Doc with a working knowledge of templates, workflows and approval process
Proficient in MS Word, Excel, Powerpoint and Outlook
Interact well with a diverse group of individuals
Self motivated and willing to be pro active in resolving issues
Demonstrate the ability to successfully interface with QA personnel.
Excellent Verbal and written communication skills. Ability to work in a team environment.
Education:BS/MS in Engineering, Life Science or Physical Science
Languages:English Read Write Speak

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