QC Sr. Associate I (Software Developer Specialist) - Fixed Term

This role is a valuable part of our Quality Control team, which is committed to ensuring data integrity, compliance, and operational excellence across our laboratory workflows. As a member of this team, you will bridge the gap between laboratory sciences and digital automation by developing specialized software configurations and automated workflows. You will have the opportunity to collaborate closely with key stakeholders across Quality Control, Validation, and end-users to optimize laboratory processes. Together, we ensure our systems meet stringent regulatory standards while maximizing efficiency to deliver life-saving therapies safely to patients., As a QC Senior Associate I (Software Developer Specialist), you will drive the automation and optimization of digital laboratory processes by designing, creating, and modifying automated workflows and “recipes” within the Biovia software system. In this role, you will bridge the gap between technical software functionality and day-to-day Quality Control laboratory operations to ensure seamless data integrity and compliance in a regulated GMP environment.

• Develop Automated Workflows: Design, create, and modify complex laboratory workflows and automated “recipes” specifically within the Biovia software system.
• Cross-Functional Collaboration: Partner with business stakeholders and end-users to gather feedback, translate business requirements, and propose new functionalities or system enhancements.
• System Testing & Troubleshooting: Detect, report, and document software defects, test new features, and support continuous system improvements.
• Optimize Reporting & Interfaces: Design and enhance user interfaces and data reporting functionalities within laboratory informatics systems.
• Maintain Compliance Documentation: Prepare and maintain detailed technical documentation and validation records following Good Documentation Practices (GDP) in a highly regulated pharmaceutical environment.
• Interface with Informatics Systems: Support the integration and functionality of laboratory software and systems such as LIMS, ELN/LES, and computerized analytical instruments.

• Educational Background: Bachelor’s degree with 8-11 years of experience, a Master’s degree with 6-9 years of experience, or a PhD with 3-6 years of experience in Computer Science (Software Development), Life Sciences (Biology, Biochemistry), or an equivalent combination of education and experience.
• Industry Experience: Minimum of 8 years of pharmaceutical industry experience, with at least 5 years specifically focused in a Software Development or Quality Control role.

Technical & Soft Skills

• Software System Expertise: Expert knowledge of computer-based systems, with an emphasis on the Biovia Software System, alongside familiarity with BPMN fundamentals and workflow design.
• Domain & Regulatory Knowledge: Solid domain knowledge in biotechnology, biochemistry, microbiology, or analytical chemistry, coupled with a strong understanding of cGMP regulations, Data Integrity concepts, and validation principles.
• Analytical Techniques: Familiarity with regulated laboratory environments and common laboratory techniques such as chromatography, spectrometry, coulometry, or particle analysis.
• Independent Project Execution: Demonstrated ability to work under limited direction, establish personal work priorities, manage timelines, and independently coordinate multiple projects.
• Communication & Interpersonal Skills: Strong verbal and written communication skills, with the ability to resolve conflicts with diplomacy and tact while collaborating effectively across international teams and with external vendors or regulatory agencies.