Sr. Validation Engineer
Newark Metro Area, NJ
The Senior Validation Specialist implements and maintains all validated equipment / systems in compliance with policies, guidelines and procedures.
Education & Experience:
* BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent
* 10 years of combined experience in FDA-regulated GMP lab environment
Must have experience validating and using common lab equipment and stand-alone computerized lab systems
Must have experience and strong working knowledge of initiating, routing, implementing, and closing change controls, investigations, and CAPA using quality management systems software, such as eQRMS, TrackWise, or equivalent
Must have experience and strong working knowledge of initiating, routing, editing, reviewing, and approving controlled documents using enterprise content management platforms, such as Documentum, VeevaVault, or equivalent
* Strong knowledge of cGXP requirements and good documentation practices related to computerized systems, equipment, and instrumentation within the pharmaceutical and biotech industry
* Advanced knowledge of 21 CFR Part 11 compliance and company Data Integrity policy requirements
* Strong knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities and manufacturing systems
* Strong experience authoring, reviewing, and approving SOPs, writing and executing system validation & equipment qualification documents, change controls, deviations, and CAPA
* Ability to interact effectively with laboratory personnel, QA, and Facilities groups
* Implements and maintains all validated equipment / systems in compliance with policies, guidelines and procedures.
* Develops and approves change controls, validation plans, qualification protocols, associated reports and procedures.
* Schedules and performs periodic review of validated computer systems
* Conducts investigations into qualification failures, develops and implements remediation plans
* Initiates, guides and reviews written procedures for calibration and preventive maintenance of common equipment and stand-alone computerized systems
* Works with other validation engineers to develop scientific approaches for calibration, equipment qualification and validation techniques.
* Initiates, manages and leads cross-functional/cross-site projects of small to medium scope and complexity.
* Manages laboratory systems implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
* Provides expert guidance to internal customer groups in the procurement, operation, and compliance aspects of computerized systems to meet business needs in accordance with required schedules or dates.
* Reviews all calibration, qualification and validation documentation for accuracy, completeness and compliance to company standards.
* Provides technical knowledge and direction as Equipment Commissioning and Qualification site representative during interactions with all cross functional groups, as required.
* Promotes and provides excellent customer service and support.
* Regularly reviews, prioritizes, coordinates and promptly responds to customer equipment qualification, system validation, and support requests.
* Provides technical support and guidance on calibration, equipment qualification and validations issues. Interfaces with customers to ensure all expectations are being met.
* Maintains a positive relationship with all the members of the Equipment Commissioning and Qualification department and site customers while promoting a positive team environment.
* Promotes and maintains compliance with corporate, safety and regulatory policies.
* Maintains all required Corporate, Facilities and EHS training as required
* Champions adherence to and improvement of all safety procedures and hazard communication