- Lead the Computerized Systems Validation (CSV) process to ensure compliance with industry regulations and standards.
- Collaborate with the Automation team to integrate CSV activities within project timelines.
- Develop and execute validation protocols, test documentation, and CSV project deliverables.
- Liaise with departments, project managers, and vendors to coordinate CSV activities.
- Provide technical support to the Automation group during field execution and report writing.
- Generate and manage project change controls as required.
- Support Design Qualification efforts and participate in risk assessments.
- Adapt to changing project requirements and timelines.
- Maintain accurate documentation and records related to CSV activities. Missions
- Bachelor's degree in a relevant field (Engineering, Computer Science, etc.) is preferred.
- Minimum of 4/5 years of experience in CSV.
- Strong knowledge and experience with PLC and DeltaV systems.
- Experience working on large-scale projects.
- Preferred familiarity with design and construction projects in biopharmaceutical manufacturing facilities.
- Excellent communication and interpersonal skills.
- Strong problem-solving and analytical abilities.
- Ability to work effectively in a team environment.
-
CSV Specialist
for 3 dage siden
Proclinical Copenhagen, Danmark PermanentCSV Specialist (Computer Systems Validation) · Position Overview: · The CSV Specialist will be responsible for designing, implementing, and executing CSV strategies and activities in compliance with regulatory requirements and industry standards. This role offers an exciting oppo ...
-
Advanced Quality Specialist
for 1 uge siden
Aeven A/S Søborg, Danmark FuldtidAdvanced Quality Specialist (GxP) for our Application Lifecycle Management (ALM) Team · Profile Summary · The Advanced Quality Specialist is responsible for ensuring the quality and compliance of the ALM Quality Center software, The Advanced Quality Specialist will perform variou ...
-
Junior QA/QC Manager: Ensuring Excellence in Global Healthcare Logistics
for 7 timer siden
DSV Hedehusene, DanmarkTime Type: · Full TimeStep into the pivotal role of Junior QA/QC Manager within our Healthcare Centre of Excellence, where you will be the cornerstone of quality assurance and control, working under the guidance of the Senior Manager to uphold and exceed international standards a ...
CSV Engineer - Copenhagen, Danmark - Consultys
Beskrivelse
MissionsJob Summary
As a CSV Engineer, you will be responsible for the Computerized Systems Validation (CSV) scope and collaboration with the Automation team. Your expertise in CSV, along with experience in large-scale projects and PLC/DeltaV systems, will contribute to the successful execution of projects in biopharmaceutical manufacturing facilities
Responsibilities