Exciting opportunity for an established client in IL.
location: Round Lake, Illinois
job type: Contract
salary: $45.83 - 53.92 per hour
work hours: 9 to 5
•Work with a small team and define Validation requirements and documentation to be used for equipment and material qualification.
•Develop protocol and unit/system test cases, scripts and plans.
•Facilitate testing activities within the team, across groups, and using third party vendors.
•Responsible for cross functional testing and documentation. Understand and follow appropriate quality validation processes.
•Validation of cleaning material efficacy
•Validation of new cleaning cycles in production equipment
•Validation of new sparyballs in process tanks
•Excellent Documentation Skills, Strong Communication Skills, Good Project Management Skills, Strong Work Ethic
•Ability to work independently and in groups, Autonomy expected.
•Flexible and adaptable to change. Handle routine tasks timely, accurately.
•Ability to walk some distance 1-3 miles, stand for 4-6 hours and lift 10-40 lbs during the course of a work day as required.
•Ability to work any shift (1st, 2nd, or 3rd) and any day of the week (7 days) as duties may require on occasion.
•Must not be allergic to Cephalosporins.
•BS/MS in Engineering or Life Sciences; Minimum 7+ years of experience as QA Validation/Engineering or as a Validation Engineer in pharmaceutical industry
•Strong knowledge of the following systems: Process Automation Systems, HVAC/ BMS, Biotech Process Equipment, Critical utilities
•Strong knowledge of qualification/validation principles and their practical applications
•Strong familiarity with regulatory/compliance environment (cGMP) associated with drug manufacture
•Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and TrackWise
•Flexible and adaptable to change.
skills: Project Management, Quality Assurance, MS-WORD, MS-EXCEL, MS-Powerpoint, GMP (Good Manufacturing Practice)
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.