Job Description: The Validation Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems 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 and systems validation. 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.
- 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.
- Develops written procedures for calibration and preventive maintenance of equipment
- 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, 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 calibration, 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.
W2 ONLY!!! NO CORP TO CORP
- BS degree in Engineering or equivalent
- Minimum 5 years of experience in FDA-regulated industry, with 5 years' experience in CSV
- 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.
- Strong working knowledge of MS Windows client and server 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
- 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
- Building Relationships
Product Quality Assurance
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Since our inception in 1999, Townsend and Associates aims to be the staffing firm both clients and professionals turn to first. Our core competencies in project staffing and full time placements are being continuously improved to be the best in class. Our markets will be solely determined by our ability to consistently deliver unequalled service to our customers and candidates.
Staffing your company with qualified and talented professionals is both challenging and time-consuming. Our goal is to make sure we understand your needs and the needs of our candidates. We research, screen and interview our consultants and employees, so we can provide you with the industries finest talent. This is why more and more companies decide to partner with Townsend & Associates, Inc.
Townsend & Associates, Inc. offers you the opportunity to work with Fortune 1000, small and medium companies for full-time or contract positions. We work together with you and our clients to create an ideal match. We discuss your career objectives, talent, experience, and what you are looking for in a new job.
Our screening research is 2nd to none. By being thorough and straight forward, we cut through a lot of challenges that arise in many job searches. So whether it’s full-time or a contract position let Townsend & Associates simplify and enhance your journey. Not Ready To Apply?
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