Validation Specialist II

Bachelor’s Degree in science, engineering, or related field
3 – 6 years proven experience in commissioning, qualification, and validation from a cGMP environment (in-house, co-op or acquired outside)
Ability to discuss normally encountered technical or project management issues, both verbally and in written form
Ability to tackle routine analytical or process related problems
Ability to perform statistical analysis of data collected throughout various projects
Must have good English written and oral communication skills

Act independently with minimal direction to conduct approved projects
Able to complete work in a variety of subject areas, including change control, protocols, analytical equipment qualification, method validation, cleaning validation, and process validation
Responsible for scheduling tasks and meeting plant requirements for area in which you are assigned
Investigate and analyze customer service problems and process improvement suggestions
Be able to defend and connect with external auditors
Develops and or lead in the development of solutions to problems specific to assigned projects
Able to lead or assist continuous improvement projects
Works with manufacturing and other functional groups on manufacturing regulatory compliance issues
Writes, implements, and reports on validation activities
Designs and performs routine testing, project experiments, analysis of data and reports results
Performs studies on new processes to optimize critical process parameters
Initiates new or revisions of protocols/operating instructions specific to the project
Performs work assignments within production department that include training, technical support and/or process trouble shooting support
Interprets, implements, and recommends modifications to operating policies where appropriate

No preferred qualifications provided.