Qualifications:
Generally requires (2-4) years related experience Validation/Project Engineer Requirements:• Bachelor's degree in engineering or a related field of specialization.• At least 2 years experience as a validation engineer in a similar industry.• Experience in equipment calibration, performance testing, and quality control.• Advanced proficiency in data analysis tools and project management software.• In-depth knowledge of production processes, parameters, and standards.• Exceptional analytical and problem-solving abilities.• Excellent leadership, collaboration, and communication skills.• Great organizational and time management abilities.• Ability to ensure compliance with industry regulations.
Responsibilities:
• Measuring production processes and parameters against industry standards.• Analyzing test data to determine the causes of defects, failure, or flaws and facilitating corrective measures.• Establishing validation standards and developing performance testing and quality control measures to ensure equipment and processes function within acceptable parameters.• Reviewing, oversight or verifying Calibration activities and certificates.• Developing test procedures and validation documentation (protocols and summary reports) that produce analyzable validation data and stand-alone reports.• Learn and perform Change Control process or operations within the company application• Performing risk assessments (FMEA and FMECA) and ensuring compliance with industry standards.• Good working knowledge of Microsoft office tools for communication and reporting.• Proven track record of process equipment implementation within a regulated environment.• Structured problem solving methodologies.• Working knowledge of project schedule software (e.g MS Project).• Documentation / Technical report writing skills.• Presenting validation test results and recommending improvements.• Training staff on validation parameters, overseeing validation activities, and documenting processes.• Keeping informed of developments and innovation in validation engineering.
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