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We're looking for a Validation Specialist II
, working in Pharmaceuticals and Medical Products
industry in 1 Discovery Drive, Swiftwater, Pennsylvania, 18370, United States
- Determine project scope.
- Use of lean/FMEA/statistical and other methods to perform preliminary options analysis.
- Change control development and execution.
- Commissioning and qualification documentation development and execution.
- Validation documentation development and execution.
- Project tracking and completion activities.
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
- Bachelors degree in Science, Engineering, or another technical field
- 3-6 years experience
- Ability to interact with end users to gather business requirements and information to be translated into project requirements and deliverables
- Ability to interface between operations and support functions, and is expected to work effectively with partner functions such as Quality and Manufacturing Technology
- Must possess strong analytical and communication skills
- Experience writing and reviewing documents following Good Documentation Practices
- Experience working in a cGMP environment required; biologics or pharmaceuticals preferred
- Must be proficient in use of Microsoft Outlook, Word, and Excel; experience with Microsoft Project, Trackwise, and statistical analysis software (SAS, jmp) preferred
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?