CSV Consultant

We are seeking a CSV Engineer to join one of our clients on a 6 to 12 months contract.

The ideal candidate will have a strong background in Computer System Validation (CSV) and Quality Assurance within the pharmaceutical and biotechnology industries. This role involves leading validation projects, managing IT infrastructure, and ensuring compliance with regulatory standards.

Key Responsibilities:

1. Lead and manage CSV projects for IT and GMP operations applications and systems.
2. Configuration and initial validation of SCADA-PLC software systems.
3. Manage the rehosting of business applications and decommissioning & archiving projects.
4. Provide lifecycle management support for business applications and industrial IT networks.
5. Validate and integrate SCADA and MES systems, including hardware and software updates.
6. Author and standardize procedures for CSV, data migration, and lifecycle management.
7. Conduct end-to-end data integrity assessments and standardize change management processes.
8. Ensure continuous quality assurance of corporate systems and compliance with regulatory standards.

Qualifications:

1. Bachelor's degree in Engineering, Computer Science, or a related field.
2. 5 years of experience in CSV within the pharmaceutical or biotechnology industries.
3. Experience in Quality Assurance within CSV is a plus.
4. Proven track record of leading validation projects and managing IT infrastructure.
5. Strong knowledge of laboratory systems, MES, and PLC systems.
6. Excellent technical writing skills and experience authoring validation documentation.
7. Familiarity with regulatory requirements and standards.
8. Ability to work effectively in cross-functional teams and manage multiple projects simultaneously.
9. Excellent communication and interpersonal skills.

Associate

Contract

Consulting, Information Technology, and Manufacturing

Pharmaceutical Manufacturing