CSV Engineer

General Requirements

This position is on-site (Lenoir, NC) and will require the employee to fulfill the following general requirements for employment at Stallergenes Greer and includes but limited to:

• Compliance with applicable standard operating procedures
• Compliance with company environmental health and safety procedures
• Protect and preserve Stallergenes Greer physical property and equipment
• Protect and preserve Stallergenes Greer intellectual property and confidential information
• The candidate will be responsible for assisting the Validation Supervisor in the creation and execution of validation projects as it relates to software.
• Practice good hygiene and personal sanitation practices

Education Requirements

This position requires the following minimum education:

• Bachelor’s Degree in Computer Sciences, Engineering or related field.

Work Experience Requirements

• Minimum of 3 years of experience in a highly regulated environment: pharmaceutical, biotechnology, medical devices or related industry
• Minimum of 1 year of experience in project management
• Strong 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 and medical devices industries
• Knowledge of Information Management, Business System (ERP), PLC or SCADA, DCS, Process Control, laboratory instrumentation, data archive/historian, Building Management Systems, etc.
• Experience in process automation

Specific Job Requirements

Job Task(s)

This position requires the following requirements for employment at Stallergenes Greer and includes but is not limited to:

• Execute pharmaceutical CSV validation project assignments including implementation of new systems, remediation of legacy, and re-validation of existing computerized systems
• Evaluate, and define technical needs and make recommendations
• Execute multiple CSV projects utilizing Project Management methodology
• Directly manage assigned projects to satisfy specific project/client needs
• Generation / execution of System Impact and Critical Aspect Assessment Impact
• Coordinate and interface with Validation Manager, 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
• 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.

Physical Demand(s)

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 standing for long periods of time on occasion.
• The position requires walking around the Lenoir Campus.
• 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 ERP or EQMS Systems is desired.
• 3 years’ experience in Computer or Equipment Validation or Programmer role in the pharmaceutical and/or medical devices industries.
• Experience in the manufacturing of pharmaceutical and/or Medical Devices