Contract position: A Validation Specialist is needed for a global healthcare leader that discovers, develops and distributes therapeutic solutions focused on patient's needs in the Swiftwater, PA area. This role is responsible for the development and execution of improvement projects for Biologics Manufacturing. No per diem available.Responsibilities for the Validation Engineer
Requirements for the Validation Engineer
- Determining 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.
- 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.
- Bachelor's degree required.
- 3+ years experience. Experience writing and reviewing documents following Good Documentation Practices.
- Experience working in a cGMP environment. Must be Proficient in use of Microsoft Outlook, Word and Excel.
- Experience with Microsoft Project, Trackwise and statistical analysis software (SAS, JMP) preferred. Biologics or Pharmaceuticals experience preferred.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.