CSV Engineer

Stallergenes Greer Ltd; North Carolina; On-site; USD 90,000 - 120,000; Full time

Job summary

Stallergenes Greer Ltd in Lenoir, NC seeks a Systems Validation Specialist to lead pharmaceutical CSV validation projects, define technical needs, and deliver validation deliverables across master plans, protocols, and summary reports.

The role requires 3+ years in a highly regulated pharma/medical devices environment, strong knowledge of FDA/GAMP guidelines, and experience with ERP/EQMS systems. On-site collaboration with Validation, Engineering, and QA teams is essential.

Qualifications

• Bachelor’s degree required in CS/Engineering or related field.

Responsibilities

• Execute pharmaceutical CSV validation project assignments including implementation of new systems, remediation of legacy, and re-validation of existing computerized systems.
• Coordinate and interface with Validation Manager, 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.

Skills

Project management

Regulatory compliance

GxP knowledge

ERP / EQMS familiarity

Education

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

Tools

ERP systems

EQMS

Calibration software

Building management software

Quality systems software

Job description

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.

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

Requirements

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

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

About STALLERGENES GREER Ltd

Stallergenes Greeris an international biopharmaceutical company specialized in the diagnosis and treatment of allergies through the development and marketing of Allergenic Immunotherapy treatments.

Our mission is to offer the full potential of precision medicine to improve the quality of life of people suffering from allergies.

Allergenic Immunotherapy (AIT) is the only treatment for respiratory allergic diseases that allows for a lasting re-education of the patient’s immune system by inducing an increasing tolerance to allergens.

With more than 1,100 employees worldwide, and production sites in Europe and the United States, Stallergenes Greer offers its medicines in 40 countries.

Would you like to participate in the development of a world expert group in its field, in a dynamic and multicultural environment ? Join our Stallergenes Greer teams !

A successful candidate will lead, manage, develop, and retain a team of planners to ensure that every part of the production process is aligned to meet the company's goals, customer needs, and [...]