Category: Innovation & Technology
Location: Newark, California

Description

Position Summary

The incumbent will be a part of the IT R&D team supporting business functions using computerized systems in the Revance Therapeutics Inc Research and Development in areas such as Quality Control, Manufacturing, Process Development and Analytical development. The administrator will be responsible for implementation of new laboratory systems and steady state activities on production systems such as user maintenance, periodic upgrades, implementing new functionality, reviewing audit trails and filing quality records as needed - Change requests, Deviation records, CAPAs.

Essential Duties/Responsibilities

• Provide technical leadership for steady state operation of supported systems and implementing new systems.
• Diagnose hardware and software problems and provide technical support to users in services, installations and training.
• Work with business owners and subject matter experts (SMEs) on IT related aspects of supported systems - determine the end user requirements, and how they can be met.
• Be the IT point of contact for user support - troubleshooting, implementing changes to the systems, creation of new users, removing users.
• Bridge between business functions and IT operations on support requests or troubleshooting items pertaining to IT infrastructure.
• Collaborate/lead/participate in decision making and make recommendations to business partners around IT aspects and computerized system functionality pertaining to business requirements.
• Generate system specific SOPs for administration of supported systems and ensure compliance with SOPs.
• Manage system maintenance and support for the computerized system.
• Support assessments for version upgrades/ new release on supported systems.
• Support and execute validation activities on supported systems.
• Assist and or develop qualification protocols as required.
• Assist with change controls, CAPAs, deviations as required.
• Support activities such as gap analysis on supported systems.
• Collaborate with Revance approved vendor personnel in coordinating IT activities on supported systems.
• Collaborate with QA on completing IT required aspects of audit trail reviews.
• Support Periodic Review activities on supported systems.
• Support Regulatory inspections and internal and partner audits, and implement corrective actions as needed.

Education

Minimum Required:

Bachelor's degree in Engineering, Science or related technological field

Preferred:

Bachelor's degree in Computer Science, Management of Information Systems (MIS), Pharmaceutical Science, Biomedical Engineering.

Experience

Minimum Required:

Minimum of three (3) years or more in the pharmaceutical industry with GxP experience.

Preferred:

Seven (5) years or more in the pharmaceutical industry with GxP experience.

Knowledge, Skills and Abilities

Minimum Required:

• Strong understanding of FDA requirements as pertaining to the Drug Development Process.
• Understanding the software development lifecycle and maintaining the system in a controlled state.
• Experience implementing computerized laboratory software in a regulated environment.
• Experience implementing enterprise systems in a regulated environment.
• Understand IT requirements for regulated computer systems - Infrastructure qualification, configuration management, Backups, patching, Disaster recovery and Business continuity requirements.
• Knowledge of automation/computerized systems within an FDA regulated environment with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.
• Demonstrate ability to effectively manage multiple projects/priorities
• Demonstrate excellent written and oral communication skills.
• Effective time management and interpersonal skills.
• Must work effectively within teams with rapidly changing priorities.
• Demonstrates analytical problem-solving skills.

Preferred:

• Relevant IT support experience with Laboratory systems and Manufacturing systems used within the pharmaceutical industry is a plus.
• Experience with Quality Control, Environmental Monitoring, Process Dev and Analytical Lab processes.
• Experience with Waters Empower software and any LIMS.
• Experience with Risk assessment and management tools.

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