Senior CSV Validation Specialist – GMP Systems

Vivid Resourcing Ltd; Limburg; On-site; EUR 92,000 - 166,000; Full time

Job summary

Vivid Resourcing Ltd is seeking a CSV Specialist for Limburg to ensure GMP IT systems stay validated. The role supports CSV activities across ERP, Electronic Batch Records, and other systems, acting as SME during external audits.

The ideal candidate holds an IT degree (Master's or Bachelor's), with several years in a pharmaceutical manufacturing environment and experience in setting up CSV studies. Flexible on freelance or payroll arrangements with 40-hour weeks.

Qualifications

• Masters or Bachelors in IT or related field.
• Experience with CSV validation in pharma/biotech is preferred.
• Knowledge of GMP guidelines and data integrity is expected.
• Knowledge of GMP guidelines and data integrity is beneficial.

Responsibilities

• Maintain and monitor validation status of GMP-critical IT systems.
• Prepare validation documents such as risk/regulatory assessments, test protocols, and reports.
• Coordinate validation studies with IT, Operations, QA and Engineering as needed.
• Ensure CSV activities comply with international regulations (GAMP 5 / Annex 11 / Part 11).
• Act as SME for CSV during external audits.
• Keep CSV Master Plan and procedures up to date.
• Identify improvements in processes, systems, and documentation.
• Assess validation requirements from proposed changes to systems.
• Initiate validation of systems, processes, installations, equipment timely.
• Ensure validation activities meet applicable legislation (GAMP 5, Annex 11, Part 11, data integrity).
• Collaborate across shared CSV systems (ERP, EBRS, Asset, A/M, Control).
• Act as SME for CSV during external audits.

Skills

CSV validation

GAMP 5

GxP compliance

QA collaboration

Education

Master's or Bachelor's in IT

Bachelor's degree in IT

Tools

ERP systems

Electronic Batch Record

Asset Management

Artwork Management

Control Systems

Job description

This position can be filled by freelance or employee consultancy via a payroll partner.

For a customer in Limburg, we are searching for a CSV Specialist to ensure that all IT systems that have an impact on GMP are maintained in a validated state.

Responsibilities

• Maintain an overview of all IT systems and the extent to which they have undergone CSV; manage and monitor their validation status to ensure that all software and hardware modifications, changes, and updates are also subject to CSV.
• Keep the Computerized System Validation Master Plan and all validation-related procedures up to date.
• Maintain an up-to-date overview of GMP-critical computerized systems and their validation status.
• Prepare specific validation documents for GMP computerized systems, such as risk assessments, regulatory assessments, test protocols, and reports.
• Set up, implement, and ensure the continued effectiveness of validation studies, or coordinate these activities, in consultation with employees from the IT department and potentially also Operations, Supply Chain, Technical Services, QA, and Engineering.
• Document, or ensure the documentation of, all validation activities and validation results, particularly those relating to CSV.
• Contribute to the improvement and optimization of personnel, processes, systems, and implemented procedures.
• Assess the validation requirements resulting from proposed changes to systems, processes, installations, or equipment, particularly changes relating to CSV.
• Initiate and carry out the validation of systems, processes, installations, and equipment in a timely manner.
• Ensure that validation activities are performed to an appropriate standard and comply with applicable international legislation and regulations concerning validation and GMP (GAMP 5 / Annex 11 / Part 11 and data integrity).
• Collaborate across the shared CSV systems, such as ERP, Electronic Batch Record, Asset Management Systems, Artwork Management, and Control Systems.
• Act as the Subject Matter Expert (SME) for CSV during external audits.

Profile

• Preferably a Master's or Bachelor's degree in IT, with at least HBO-level professional and intellectual ability.
• Several years of experience within a pharmaceutical manufacturing environment is an advantage.
• Experience in setting up and managing CSV or other validation studies is an advantage.
• Familiar with GMP guidelines, pharmaceutical guidelines, hygiene requirements, etc.
• Knowledge of GAMP 5.
• Experience with quality systems, procedures, training, etc.

SENIORITY: Medior/Senior

START DATE: October/November (ASAP)

DURATION: 12 Months

EXTENSION: Yes

CONTRACT: Freelance or Consultant (payroll)

LOCATION: Limburg

ONSITE POLICY: Flexible - TBD

HOURS PER WEEK: 40

INTERVIEW PROCESS: 1-2 stages

If you are interested, please forward your updated resume to [e-mail] to be considered.