- Reference ID: Med006
- Type: Permanent
Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalification’s. 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 prepare 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’s 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. Programs and operates department analytical instruments (such as temperature/humidity data loggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
- Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
- Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
- 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)
- Preparation and execution of protocols for new and existing equipment, facilities and process qualification, including IQ, OQ, PQ and requalification.
- 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).
- 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.
- Evaluate, recommend and implement measures, after consultation with QA and Management, which result in continuous improvement in equipment performance, product quality and integrity.
- Ensure that all activities related to equipment and process validations are maintained within cGMP, ISO and QSR compliance.
- Provide support for lab instruments (identification for purchase, operation, qualification and calibration).
- Assist in execution of the scheduled preventative maintenance and calibration activities.
- Execute and support the facility qualifications and commissioning activities.
- Support the purchase and implementation of new equipment and systems.
- Coordinates activities of outside validation contractors to ensure validation projects are completed on time and in compliance with Medefil and regulatory standards.
- Perform all work in a safe manner.
- Perform other duties as assigned.
- Bachelors Degree in a Science field preferred.
- BS/BA degree in science, engineering, manufacturing technology or closely related field or equivalent experience in a manufacturing facility
- Minimum 1-3 years pharmaceutical manufacturing experience
- 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
- Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results
- Strong conflict resolution skills
- Must be willing to travel both domestically and internationally
- Must be able to work multiple shifts as needed to meet deadlines