Cleaning Validation Engineer
Description
Essential Duties and Responsibilities
Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. 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.
Qualifications
● 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.