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

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.