Senior QC Technician

Description:

What you will do

• Create automated laboratory workflows and support development of laboratory “recipes” within the Biovia software system.
• Collaborate with business stakeholders to gather feedback and propose new functionalities
• Report defects, test new software features, and support system improvements
• Design and enhance reporting functionalities and interfaces within laboratory systems
• Work with end users to design and optimize complex workflows and processes
• Prepare and maintain documentation in regulated laboratory environments

What we are looking for

• An individual with the ability to create new and/or modify existing Biovia based recipes for use within the Quality Control Laboratory. 
• Domain knowledge in biotechnology, chemistry, biochemistry, microbiology, analytical chemistry, or related fields
• Experience working in a regulated laboratory environment (ISO or GMP)
• Experience with laboratory techniques such as chromatography, spectrometry, coulometry, or particle analysis
• Good understanding of laboratory processes (certification, IPC, sample cycle, etc.)
• Experience in creating documentation (GDP)
• BPMN fundamentals and ability to work with end users on workflow design
• Understanding of Data Integrity concepts
• Strong analytical, communication, and problem-solving skills
• Proactive attitude and ability to work effectively in international teams

Nice to have

• Knowledge of Ph. Eur, USP, ICH, MHRA, and related standards
• Experience with LIMS systems (LabWare, CoreLims, LabVantage)
• Experience with ELN/LES systems (especially ONELab from Biovia)
• Experience with laboratory software such as Empower, LabX, Chromeleon, MassHunter, or OpenLab
• Knowledge of CSV, GAMP5, 21 CFR Part 11, and EU Annex 11
• Experience in pharmaceutical method validation, cleaning validation, or instrument qualification
• Familiarity with Agile methodologies (Scrum, SAFe) and Business Analysis concepts
• Understanding of code versioning concepts

Education and Experience 

• BS/BA degree and 8-11 years experience in Computer Science (Software Development) or Life Science (Biology, Biochemistry) or Equivalent 
• Masters degree and 6-9 years experience in Computer Science (Software Development) or Life Science (Biology or Biochemistry) or  Equivalent 
• PhD/JD and 3-6 years experience in Computer Science (Software Development) or Life Science (Biology or Biochemistry) or Equivalent  
• Minimum 8 years pharmaceutical experience 
• Minimum 5 years experience in Software Development role or Quality Control. 

Work Environment

• Works in an office environment. 
•  May be exposed to hazardous materials and chemicals. 
• May be required to lift up to 30lbs