CSV​/Data Integrity Engineer

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world’s most complex challenges and deliver more impact together.

Arcadis is seeking an CSV / Data Integrity Engineer with pharmaceutical/biotechnology industry experience to support data governance and data integrity activities for new capital equipment being added to the site. In this role, you will generate and maintain data governance documentation, support system qualification activities, and help identify and remediate compliance gaps to ensure equipment and systems meet current data integrity and GMP requirements.

• Generate data governance documentation for new capital equipment being added to the site, including System Classification Forms (SCF), Configuration Specifications, User Requirement Specifications (URS), Data Integrity Risk Assessments (DIRA), Data Security Assessments (DS), and Audit Trail Risk Assessments (ATR).
• Deliver documentation in alignment with approved project timelines.
• Attend project review meetings and provide status updates as required.
• Develop and execute SIQ/SOQ protocols, where required, to verify system qualification and traceability to data governance documents.
• Review existing data integrity (DI) documentation and update as required to align with current client document templates.
• Support the transfer of existing data governance documents from Aveva One Vault to KNEAT.
• Identify additional compliance gaps and propose remediation requirements in collaboration with the team.
• Support with user management and audit trail documentation requirements for standalone equipment.
• Assist in developing system data maps that show how data moves between assets and other quality systems.

• Experience in the pharmaceutical/biotech industry.
• Bachelor’s degree in Engineering, Life Sciences, Computer Science, Information Systems, or a related technical/scientific discipline preferred.
• Experience working in a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
• Experience with data integrity, data governance, computerized systems, CSV, CQV, or equipment qualification.
• Hands-on experience developing or reviewing regulated documentation such as URS, system/configuration specifications, risk assessments, qualification protocols, and traceability documentation.
• Knowledge of data integrity principles, audit trails, user access/security controls, and computerized system compliance.
• Experience identifying compliance gaps and supporting remediation activities.
• Ability to develop or interpret system data flows/data maps and understand how data moves between standalone equipment and connected quality systems.
• Experience with KNEAT is highly desirable.
• Experience with AVEVA One Vault or similar controlled document management systems is preferred.
• Strong technical writing, documentation, organization, and cross-functional communication skills.
• Ability to manage multiple documentation deliverables while working against established project timelines.

We can only achieve our goals when everyone is empowered to be their best. We believe everyone's contribution matters. It’s why we are pioneering a skills-based approach, where you can harness your unique experience and expertise to carve your career path and maximize the impact we can make together.

You’ll do meaningful work, and no matter what role, you’ll be helping to deliver sustainable solutions for a more prosperous planet. Make your mark, on your career, your…