Validation Specialist IV
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The Opportunity
Description
We're looking for a Validation Specialist IV, working in Pharmaceuticals and Medical Products industry in 1 Discovery Drive, Swiftwater, Pennsylvania, 18370, United States.- Work closely with subject matter experts (SME) to generate validation documents compliant with the site policies and procedures.
- Perform validation sampling and data analysis of the results.
- Ensure proper execution/documentation of test results, and compilation of validation packages.
- Retrieve and compile data from electronic sources / databases and paper records.
- Analyze data.
- Responsible for authoring, reviewing, executing and approving validation documents.
- Assist in writing Standard Work Instructions and Batch Production Records.
- Provide Fermentation Expertise.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Experience in writing protocols/reports in Pharmaceutical Bio Pharma Validation industries to include Process Validation. Experience with fermentation processes
- MS Office 2010, E Doc, Pharmaceutical Validation, Bio Pharma Validation, Validation execution, Technical writing abilities and good time management
- Strong root cause analysis skills with cGMP experience
- Excellent Verbal and written communication skills
- Ability to work in a team environment
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
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