Senior Computer System Validation Engineer
Location:
Bern, CH
Your tasks include
- Plans, coordinates, and executes assigned projects by effectively using Project Management methodologies
- Reviews and approve CSV-related system lifecycle design documentation (user requirements, functional and design specifications, commissioning, and qualification protocols)
- Perform hands-on field work for equipment, aseptic processing, steam sterilization, cleaning validation, and process validation and their associated control systems
- Uses proven monitoring and problem-solving techniques such as SPC and DMAIC
- Providescustomer focus supporting engineering, research and development, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert and leader within the Commissioning and Qualification department
- Solves a range of varied and complex problems requiring analysis/interpretation and are solved using knowledge/skills, precedents, and practices. These include but are not limited to process troubleshooting, operations support, root cause analysis, and risk assessment to document and accept the risk
- Actsas a coach and mentor to other members of EFV and project teams to drive continuous improvement, knowledge transfer, and professional growth of self as well as colleagues
- Identify areas to drive down project costs through lessons learned and develop specific improvement strategies to realize these savings.
- Has wide-ranging experience, using professional concepts and company objectives to resolve complex issues in more efficient ways than lower levels.
- Works on complex issues where analysis of situations/data requires an in-depth evaluation of variable, identified factors.
- Exercises judgment normally in selecting methods, techniques, and evaluation criteria in resolving issues.
- Determines own instructions and procedures on day-to-day tasks and new assignments.
- Drives the complete execution of assigned projects in a manner that drives high engagement from project team members
What you bring to the table
- A minimum of 5 years of experience in a biopharmaceutical or related environment in the area of system qualification or validation
- BS/MSc in IT or equivalent with a strong track record in Biotech-Industry,
- Project/Program Management
- Technology/Equipment (DP/DS/Clinical/Commercial/SS/SU) emphasis will vary by site, the candidate is expected to be able to guide the site to top-quartile operational safety, efficiency, and compliance for these technologies
- Ability to think and act both strategically and tactically
- Highly effective verbal and written communicator at all levels of the organization
- Demonstrated ability to effectively prioritize and coordinate activities
- Proficiency in Microsoft Office applications and validation-specific software programs
- Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity
- Possesses strong knowledge of current validation best practices, including governmental regulations and GxPs.
- Subject Matter Expertise in Computer Systems Validation
- Languages: German and English, oral and written