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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:
• Strong 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.
Competencies:
• Technical / Professional Knowledge
• Problem Solving / Troubleshooting
• Action Oriented
• Attention to Detail
• Multi-tasking
• Building Relationships
Education & Experience:
• 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
Great News! We've discovered an exciting live job opportunity for a Validation Engineer position in Summit. This job is currently open for hiring/recruiting by TSR, exclusively for you at American Jobs. Feel free to download the job details here.
The work culture at TSR must adhere to the Ethics of Work Culture as described in the Ethical framework of the UN Charter. You can gain more insights into their local workplace environment by exploring their jobs TSR and also by visiting their official website through Google.
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Validation Engineer jobs are available in United States.
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The average salary range for Validation Engineer in Summit varies, but the standard pay scale is rated "Standard" in Summit. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively.
To apply for a job at TSR follow the application process following the "Apply Now" button at American Jobs and also you can visit TSR official career page and follow their application process.
Key qualifications for Validation Engineer typically include a list of qualifications and expertise as outlined in Bureau of Labor. Be sure to check the specific job listing for detailed requirements and qualifications.
You can set up job alerts for Validation Engineer in Summit by creating a free job alerts on American Jobs. Our Ai system will automatically notify you when new job listings matching your criteria become available.
Benefits for Validation Engineer positions may include a list of benefits. These can vary from company to company, so it's important to review the specific job listing for details on benefits offered by the employer.
Not all jobs have remote job opportunities available. However, nowadays, many companies offer remote work options. You can find remote job listings for Validation Engineer on American Jobs.
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