Validation EngineerTSR • Summit, NJ
Validation Engineer
TSR • Summit, NJ
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- serp_jobs.job_card.temporary
job_description.job_card.job_descriptionStrong working knowledge of MS Windows client and server technologies. Working knowledge of standard networking principles and technologies Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance Ability to work with the end user to identify and document User and Functional Requirements Knowledge of pharmaceutical laboratory and manufacturing systems. 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, Visio 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 Multi-tasking Building Relationships BS degree in Engineering / Computer Science or equivalent experience (degree not required) 5 years of experience in FDA-regulated industry, with 5 years experience in CSV
Summary
Reports, Change Controls.
- Manages projects of varying scope and complexity.
- Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
- Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems
- 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 qualification and validation documentation with accuracy, completeness and compliance to Company 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.
Required Competencies-Knowledge, Skills, and Abilities :
Competencies :
Education & Experience :
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Validation Engineer • Summit, NJ
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