Validation Engineer II
Discovery Drive, SWDD Swiftwater, PA
Responsible for development and execution of improvement projects for Biologics Manufacturing. Responsibilities include 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.
- Must possess strong analytical and communication skills.
- 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 Microft Project, Trackwise and statistical analysis software (SAS, JMP) preferred
- Biologics or Pharmaceuticals experience preferred
- Technical Degree
- 3-6 years' experience
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.