Validation Engineer III

Job Summary

Our team has an exciting opportunity for a Validation Engineer III for a well established pharmaceutical manufacturing company. The candidate will be responsible for testing (measure, analyze, and verify specifications) the equipment, processes, and systems used to develop or manufacture pharmaceutical products.

Job Responsibilities:

• Develop and generate validation protocols associated with equipment, systems, and processes used in the SHC facility.
• Directly and indirectly support the execution of validation protocols (IQ/OQ/PQ/CVP/CSV), including the collection of samples, data, and completes protocol attachments, as requested.
• Directly and indirectly compiles and analyzes validation data, prepares reports, and makes recommendations for changes and/or improvements.
• Ensures that Validation management is notified of deviations from protocol criteria, supports the identified root causes and resolutions.
• Directly and indirectly, supports the investigation of deviations, troubleshoot problems, and determines solutions.
• Coordinates the scheduling of validation protocol executions and testing with affected departments and personnel; this will include Manufacturing, Quality assurance/Control, and Maintenance.
• Accurately documents the results of a protocol execution and qualification tests.
• Directly and indirectly, supports the generation of SOPs.
• Directly or indirectly identify and define project and process improvement opportunities
• Support the development of project plans and timelines.
• Support the tracking of project goals and work within cross-functional teams.
• Train equipment operators or other staff on validation protocols and standard operating procedures, as required.
• Provide technical review of equipment orders and consult when requested.
• Support the execution of Factory Acceptance Testing (FAT) and/or Site Acceptance Testing (SAT) on purchased equipment, when appropriate.
• Oversee the activities of and provide leadership to the Validation Technician(s) and Validation Engineers I and II, as requested.
• May be required to perform other duties as assigned or as needed.

Job Qualifications Required:

• Bachelor's degree in Engineering, Biology, or Chemistry is the minimum qualification
• Minimum of 4-7 years of validation experience in a pharmaceutical, homeopathy, nutraceutical, dietary supplement manufacturing company with tableting experience.

Knowledge, Skills & Abilities:

• Follow pharmaceutical industry standards in generating and updating documentation such as P&IDs, material and equipment specifications, and requirement specifications.
• Ability to work under pressure and perform tasks on schedule with supervision.
• Good communication skills both oral and written. Able to communicate progress effectively.
• Disciplined to consistently follow Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and safety precautions.