Validation Engineer

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