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AGC Biologics

End-to-end biopharma CDMO for gene therapies

Validation Scientist - Computer System Validation

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeHeidelberg, Germany

About the Job

Requirements

  • A completed master's degree in computer science, automation engineering, electrical engineering, biotechnology, chemical engineering, or process engineering, with a focus on computer system validation topics.
  • Substantial experience in Computer System Validation (CSV) according to GAMP5, including validation of automation, MES, LIMS, or ERP systems.
  • Knowledge of regulatory requirements including 21 CFR Part 11, EU Annex 11, and Data Integrity/ALCOA+.
  • A valid work permit is required.
  • Very good German and English language skills are required.

Responsibilities

  • Plan, organize, and conduct validation and qualification of equipment, systems, and facilities in production, QC, and warehousing according to applicable GMP regulations.
  • Support FATs/SATs for qualification activities (IQ/OQ/PQ) and prepare complete qualification documentation.
  • Take technical responsibility for Computer System Validation, including GAMP5-compliant validation of IT and automation systems such as MES, LIMS, SCADA, process control systems, and control technology.
  • Assess and qualify change requests affecting computerized systems.
  • Act as the internal CSV subject-matter expert and support CSV matters during audits and inspections.
  • Create and review CSV-related documents, including SOPs, URSs, FSs, DSs, risk assessments, test plans, and test scripts.
  • Support Production, QC, and Engineering with technical tasks, changes, optimization measures, and new acquisitions.
  • Work with QA Systems and QA Operations to ensure compliance with relevant GMP regulations.
  • Coordinate closely with Engineering, Production, QC, and Supply Chain Management.

Desired Qualifications

  • Experience in qualification or validation in the pharmaceutical or biotechnology industry is advantageous.
  • IT experience with document management systems such as TrackWise, computerized maintenance management systems such as BM RAM, and databases is advantageous.

About the Company

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AGC Biologics

End-to-end biopharma CDMO for gene therapies

AGC Biologics is a global contract development and manufacturing organization (CDMO) that develops and manufactures biopharmaceuticals, including therapeutic proteins, plasmid DNA, viral vectors, and cell therapies. It offers end-to-end services from early development through commercial-scale manufacturing, with fast-track options for orphan drugs and rare diseases. The company runs cGMP-compliant facilities across the US, Europe, and Asia, recently expanding with a Longmont, Colorado site focused on cell and gene therapies. Its goal is to help biopharma partners bring new treatments to market efficiently and safely by providing integrated development and manufacturing, supported by its international footprint and project acceleration capabilities.

Company size
1,001-5,000
Company stage
Acquired
Total funding
$557.7M
Headquarters
Bothell, WA
Founded
2001

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