Validation Engineer

Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalification. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must have a comprehensive understanding of cGMPs and become certified to enter Controlled Areas of the plant (Grade D, C, and up to B/ A). The ability to write reports clearly, concisely and accurately; accurately record data, and a basic understanding of statistical analysis is also required to perform these duties. 

The Validation Engineer will be responsible for maintaining all the documentation of the executed protocols and preparing summary reports as required for the projects. Reporting to the Engineering Department Head, specific duties include (but not limited to):

• Schedules and executes equipment requalification per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Analyzes data, composes a final report and circulates for approval. Executes equipment validation studies to include protocol preparation, scheduling, protocol execution, and final report preparation.
• Participates in presentation of results to Regulatory Agency when necessary.
• Perform the IQ, OQ, and PQ required for the chambers (examples, stability chambers, incubators, refrigerators, ovens, freezers, and muffle furnace, etc.) involving the temperature and humidity mapping activities. Also responsible for the validation of Sterilizers and SIP cycle as required for the products and parts.
• Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
• Participates in teams assembled to install, validate, troubleshoot and maintain systems and equipment.
• Participate and lead the cleaning validation program to ensure it meets the compliance requirements, and the processes are designed and validated to ensure there is no risk of cross –contamination.
• Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• Maintain compliance to the validation department operating policies, procedures, and validation/qualification protocols; as well as, the requirements and/or guidelines specified by FDA, OSHA, and other governmental agencies.
• Maintain the Validation Master Plan (VMP). Administer, create and execute protocols for new and existing equipment, facilities and process qualification, including IQ, OQ, PQ and requalification.
• Monitor workload schedules to optimize efficiency, validation simplification, and ensure compliance with project schedules, cost, and quality.
• Preparation of supporting validation documents to support ISO, QSR standards; i.e., Functional Specifications (FS), Functional Risk Assessment (FRA), Good Automation Manufacturing Practices (GAMP), GxP Assessment, Qualification Strategy Document (QSD), User Requirement Specification (URS) and Factory Acceptance Testing (FAT).
• Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity.
• Write new, revise existing, and implement required validation SOPs.
• Maintain the equipment, facility, and process requalification plan/schedule.
• Responsible for completing investigation reports related to NOE, OOS events related to equipment, facility, and process validations.
• Participate in design reviews and Risk assessment projects.
• Have an understanding of PLCs, HMIs, Robots, and Vision systems about all the validation activities.
• Communicate ideas and comprehend information both verbally and in written form.
• Make recommendations for quality and cost improvements.

Education Minimum / Recommended:

• Degree in Engineering or equivalent in a related field.

Work Experience Required:

• 3 -5 years related pharmaceutical / medical device experience in the field of validation and compliance.

Skills (Reading, Writing, Verbal Communication, Mathematics, Computer, etc.):

•            Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices

•            Strong technical knowledge and experience with pharmaceutical process, sterilization, and cleaning validation as related to sterile products

•            Must be proactive, have experience with high performance teams, strong interpersonal and project management skills

•            Must be able to interact with varying levels within the company

•            Must be able to work multiple shifts as needed to meet deadlines

• Strong communication and interpersonal skills
• Demonstrate ability to work in cross-functional team environment. The ideal candidate will possess excellent planning and coordination skills and be able to adapt to changes in priorities and project schedules readily.