Skye Blue Consulting has been engaged to find a Computer systems validation supervisor for one of our top clients in Western North Carolina. The client is a small (but growing!) pharma firm with competitive salaries, great benefits and is located in the beautiful foothills area.

• The candidate will be responsible for assisting senior level personnel in the creation and execution of validation projects as it relates to software. Core responsibilities include, but are not limited to: engaging end user for the purpose of source documentation (URS/FRS) generation, development of test scripts, installation, operational and performance qualifications, and system configuration and failure resolution.

Job Task(s)

This position requires the following requirements for employment includes but not limited to:
• Plan, schedule, execute, and lead pharmaceutical validation project assignments including: implementation of new systems, remediation of legacy, and re-validation of existing computerized systems
• Evaluate, define, and define technical needs and make recommendations
• Prioritize, manage, and execute multiple projects utilizing Project Management methodology
• Perform business development activities
• Directly manage assigned projects to satisfy specific project/client needs
• Generation / execution of System Impact and Critical Aspect Assessment Impact
• Coordinate and interface with project managers, as well as engineering and quality assurance groups to ensure successful project execution
• Lead cross-functional project teams in the development of validation deliverables
• Review and approve validation project documentation
• Develop validation deliverables including master plans, protocols and summary reports, as required
• Support development of best practices within the validation group, based on current industry practices and guidelines

Education Requirements

This position requires the following minimum education:
• Bachelor’s Degree

Work Experience Requirements

• Minimum of 10 years of experience in a highly regulated environment: pharmaceutical, biotechnology or related industry
• 2 to 3 years of experience in project management (preferred)
• Knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation
• Familiar with off-the-shelf, configurable, and custom-developed applications
• Knowledge of validation deliverables associated with each step of the computer system life cycle
• Experience with various technologies and automated systems used in the pharmaceutical industry
• Information Management, Business System (ERP), PLC or SCADA, DCS, Process Control, laboratory instrumentation, data archive/historian, etc
Experience in process automation an asset
• Experience in pharmaceutical/biotech manufacturing an asset

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The position requires sitting and stand for long period of time on occasion
• The position requires occasional travel

Computer Skill(s)
• To perform this job successfully, an individual should have knowledge of Microsoft Office, quality systems’ software, calibration software, building management software and ERP systems.

Additional Skill(s)
• 1-2 years’ experience with JD Edwards One World is desired
• 5 years experience in a managerial/supervisor role in the pharmaceutical industry

All your information will be kept confidential according to EEO guidelines.