Cleaning Validation Engineer

Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.

This position involves cleaning validation, cleaning cycle development and post-cleaning validation monitoring in a cGMP facility. Below is a list of requirements for eligibility and success in this role.

●        Hands-on experience with the following systems: CIP systems (skids), SIP systems, washers (glass and parts), vessels, tanks, COP, and manual cleaning.

●        Experience with the development and execution of manual cleaning protocols, cleaning validation protocols, and final reports.

●        Experience troubleshooting CIP system failures and optimizing CIP/COP systems including manual processes and CIP equipment (developing CIP/COP Cycles is preferred).

●        Analyze data, determine results, and present conclusions and recommendations ensuring that projects are implemented in accordance with the agreed scope, timelines, policies, and procedures.

●        Generate and resolve protocol discrepancies or deviations.

●        Review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation.

●        Train operations staff on protocols, procedures, and technical details related to systems or processes.

●        Organize, schedule, and track validation activities to meet client requirements and agreed timelines.

●        Experience with different sampling techniques.

●        Working knowledge of cGMP requirements and strong written and verbal communication skills are required for this position.

●        Experimental design and problem-solving skills are preferred. Strong organizational skills and demonstrated ability to manage projects to completion are highly desired.

●        Experience in discrepancy and non-conformance reporting, corrective action/preventive action systems and root cause analysis is preferred.

Requirements

●        Engineering Degree required. 

●        Working knowledge of FDA and cGMP regulations and documentation practices.

●        Proven ability to review, interpret and make scientific conclusions and recommendations based on data.

●        Excellent written and verbal communication and technical writing skills.

●        Proficient in Microsoft Office Suite and able to learn new computer applications.

●        Results-oriented with hands-on experience with validation execution, familiar with industry concepts, practices and procedures in a cGMP environment.

●        Strong problem solving and decision making skills.

●        Ability to understand and extract necessary information from technical documents.

●        Takes initiative to help drive projects forward and develop contingency plans when applicable.

●        Able to effectively manage workload and prioritize activities.

●        Ability to work independently, handle multiple tasks simultaneously and to meet critical milestones and goals.

●        Effectively work within a team environment and interface with peers, management, etc.

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.