No C2C third parties Please

DUTIES AND 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 equipment qualification and systems 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 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.

EDUCATION:

Required BS degree in Engineering / Computer Science or any related field.

QUALIFICATIONS:

• Minimum 5 years of experience in FDA-regulated industry, with 5 years experience in CSV.
• 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.