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Validation Engineer

Newark Metro Area, New Jersey

Post Date: 07/11/2017 Job ID: JN -072017-19503
Position Overview:

The Equipment Engineer supports the successful implementation of laboratory equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

Essential Functions:

Maintains all qualified equipment systems in compliance with policies, guidelines and procedures.
Develops qualification protocols, and associated reports while adhering to a change management process.
Supports the execution of equipment qualifications and validation protocols
Supervises vendors for qualification functions.
Develops written procedures for calibration and preventive maintenance of equipment
Supports calibration, equipment qualification and validation activities.
Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.

Manages projects of limited scope and complexity within their functional area.
Supports laboratory equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
Completes all calibration, qualification and validation documentation with accuracy, completeness and compliance to the client's standards.

Provides excellent customer service and support.
Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
Maintains a positive relationship with all team members and site customers while promoting a positive team environment.

Knowledge, Skills & Abilities:

Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
Familiarity with 21 CFR Part 11 compliance
Knowledge of pharmaceutical laboratory and manufacturing systems. Preferred experience with Kaye validators, BSCs, refrigerators, welders, etc.
Experience executing equipment qualification documents
Ability to interact effectively with laboratory, QA, and Facilities groups
Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously
Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation
Strong computer skills in Microsoft Office Suite Word, Excel and Outlook, and the ability to learn new software as required for equipment qualification.

Technical / Professional Knowledge
Problem Solving / Troubleshooting
Action Oriented
Attention to Detail
Building Relationships

Education & Experience:
BS degree in Engineering or equivalent
Minimum 5 years of experience in FDA-regulated industry, with 3 year experience in equipment qualification.

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