Senior Validation Specialist
Warren, New Jersey, US Warren, NJ 07059
Job Title: Senior Validation Specialist
Location: Warren, New Jersey, US
Job Type: Contract
Duration: 6 Months With Possible Extension
- The Senior Validation Specialist implements and maintains all validated equipment / systems in compliance with policies, guidelines and procedures. Through this work, the incumbent supports the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers. The incumbent identifies issues or unmet needs and initiates projects or programs to address them. This individual works independently to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge. The incumbent will be heavily involved with deviations, investigations and change controls.
- 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 calibration, qualification and validation documentation for accuracy, completeness and compliance to the 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
Education & Experience:
- BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent
- 7 years of combined experience in FDA-regulated GMP lab environment
- **VERY IMPORTANT ***
- 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
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Recruiter: Debasis Banerjee