In this role, you will be responsible for the commissioning, qualification, and validation of visual inspection equipment and related systems on a pharmaceutical manufacturing site. You will ensure compliance with regulatory standards, support vendor coordination, and drive continuous improvement in the validation processes. The position requires experience with Automated and Semi-Automated Visual Inspection systems and container closure integrity testing.

Start Date: ASAP

Duration: 18 Months

Place of Work: Stein (AG)

Key Responsibilities

  • Planning, coordinating, and executing commissioning and qualification activities for visual inspection systems, including AVI, SVI, and CCIT equipment
  • Developing and reviewing validation documents such as IQ, OQ, PQ protocols, and final reports in line with industry standards and regulations
  • Supporting the validation of auxiliary equipment like lighting meters and leak detection systems
  • Collaborating with CSV and IT teams to ensure seamless integration and support during validation phases
  • Leading testing activities with external vendors or contractors and ensuring adherence to validation plans and protocols
  • Maintaining comprehensive documentation, tracking issues, and implementing corrective actions as needed
  • Supporting updates to validation master plans and participating in continuous process improvement initiatives
  • Facilitating communication with cross-functional teams, leading coordination meetings, and reporting validation status to project stakeholders
  • Managing changes within the validation scope, ensuring proper change control and documentation
  • Ensuring timely completion of validation milestones and compliance with regulatory requirements

Candidate Profile

  • Degree or professional qualification in Engineering, Life Sciences, Chemistry, Biotechnology, or related fields
  • At least 5 years of experience in commissioning, qualification, or validation within a GMP environment, preferably in pharmaceuticals, biotech, or medical devices
  • Hands-on experience with Automated and Semi-Automated Visual Inspection systems and container closure integrity testing methods such as Vacuum Decay or HVLD
  • Proven ability to develop and review IQ/OQ/PQ protocols and reports
  • Strong knowledge of GxP, FDA, EMA, ISO standards, and regulatory frameworks
  • Excellent problem-solving skills and the ability to troubleshoot complex systems under pressure
  • Effective communication skills in English; German language skills are a plus
  • Experience with validation tools like Kneat and validation methodologies such as Knapp Validation is advantageous
  • Ability to work independently, prioritize tasks, and manage multiple deadlines

 

Job ID 41180971