A validation and quality assurance provider are looking to hire a Cleaning Validation Specialist for their Greenbush, NY project site. This unique group works to develop and blueprint a universally implemented validation process that reliably achieves quality, affordable and available healthcare products.
Hourly rate $50.00 to $60.00
This is a six month + assignment with the potential of being extended. Vaporized Hydrogen Peroxide (VHP) initial qualifications and requalification’s. Equipment Experience: Fill Finish and Isolators Scope of work:  Draft and obtain pre-approval on Developmental and Initial Validation protocols for cleaning validation for clean in place (CIP) and clean out of place (COP) equipment. Drafting includes determining swab and sample locations, determining worse case equipment, specifying recipe parameters for validation cycle, specifying client’s acceptance criteria, etc.  Soil equipment with riboflavin solution or product for testing and Clean Hold Studies  Execute cleaning validation studies, perform visual verifications to verify equipment is clean, collect swab samples, collect rinse samples, submitting samples to laboratory  Draft and obtain final approval cleaning validation summary reports containing summary of execution, sample results and test results.  Education 
BS Degree in Engineering/ STEM discipline or related technical degree. Related experience in the Engineering and pharmaceutical fields will be considered. 
Requirements  Strong organizational, excellent writing and communications skills. Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.  Ability to be flexible to address both shifting priorities and changes in approach in dynamic work environments.  Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.  Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.  Experience  At least two to five years of experience in cleaning validation. Additional experience in SIP or CIP validation is a plus.  Prior practical experience at a GMP facility in a Process Engineering, Facilities or Operations role with skills that transfer to CQV duties also considered.  Ability to be flexible to address both shifting priorities and changes in approach in dynamic work environments.  Strong leadership, verbal communication, technical writing, project management tools and word processing skills.  Experience related to the commissioning and qualification of clean/dirty utilities, process support systems, and process equipment.  Generation and supporting the troubleshooting and close out of discrepancies and deviations.  Experience in Computer system assessment and 21 CFR Part 11 experience is a plus. 
Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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