Validation Engineer
Validation Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Maintains all qualified and validated equipment and systems in compliance with policies guidelines and procedures.
- Develops 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.
- Supports calibration equipment qualification and validation activities.
- Configures and documents the configuration of computerized systems.
- Develops validation/qualification deliverables such as Validation Plans Requirements Specifications Traceability Matrices Summary Reports and 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.
Requirements:
- Required BS degree in Engineering / Computer Science.
- Minimum 5 years of experience in FDA-regulated industry with 3 years experience in CSV.
- Environment may include working in office or in a laboratory / manufacturing area.
- Ability to work safely in an environment with hazardous radioactive and infectious materials and waste.
- Ability to work safely when working alone or working with others.
- 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.
- Technical / Professional Knowledge.
- Problem Solving / Troubleshooting.
- Action Oriented.
- Attention to Detail.
- Multi-tasking.
- Building Relationships.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
