Laboratory Informatics Specialist BIOVIA

Client is seeking a Senior BIOVIA Laboratory Workflow Developer to create and enhance automated laboratory workflows and BIOVIA-based recipes for a Quality Control laboratory. One of the following education and experience combinations: BS or BA in Computer Science, Software Development, Life Science, Biology, Biochemistry, or an equivalent field, plus 8–11 years of experience.

Overview

Client is seeking a Senior BIOVIA Laboratory Workflow Developer to create and enhance automated laboratory workflows and BIOVIA-based recipes for a Quality Control laboratory. This role combines laboratory informatics, software development, workflow design, and regulated pharmaceutical laboratory experience.

Core Responsibilities

• Create automated laboratory workflows and develop or modify laboratory recipes within the BIOVIA software system.
• Partner with business stakeholders and end users to gather feedback, define requirements, and propose new functionality.
• Design and optimize complex laboratory workflows and processes.
• Report software defects and test new features and system improvements.
• Design and enhance laboratory-system reporting capabilities and interfaces.
• Prepare and maintain documentation in regulated laboratory environments.

Essential Qualifications, Skills, and Technologies

• Hands-on ability to create or modify BIOVIA-based recipes for use within a Quality Control laboratory.
• Domain knowledge in biotechnology, chemistry, biochemistry, microbiology, analytical chemistry, or a related field.
• Experience working in an ISO- or GMP-regulated laboratory environment.
• Experience with laboratory techniques such as chromatography, spectrometry, coulometry, or particle analysis.
• Understanding of laboratory processes, including certification, in-process control, and the sample lifecycle.
• Experience creating documentation following Good Documentation Practices.
• Knowledge of BPMN fundamentals and experience designing workflows with end users.
• Understanding of data-integrity concepts.
• Minimum eight years of pharmaceutical experience.
• Minimum five years of experience in a software-development or Quality Control role.
• One of the following education and experience combinations:
  • BS or BA in Computer Science, Software Development, Life Science, Biology, Biochemistry, or an equivalent field, plus 8–11 years of experience.
  • Master's degree in Computer Science, Software Development, Life Science, Biology, Biochemistry, or an equivalent field, plus 6–9 years of experience.
  • PhD or JD in Computer Science, Software Development, Life Science, Biology, Biochemistry, or an equivalent field, plus 3–6 years of experience.
• Strong analytical, communication, and problem-solving skills.
• Proactive approach and ability to work effectively with international teams.

Preferred Skills or Experience

• Knowledge of Ph. Eur., USP, ICH, MHRA, or related standards.
• Experience with LIMS platforms such as LabWare, CoreLIMS, or LabVantage.
• Experience with ELN or LES platforms, particularly BIOVIA ONE Lab.
• Experience with laboratory software such as Empower, LabX, Chromeleon, MassHunter, or OpenLab.
• Knowledge of computer system validation, GAMP 5, 21 CFR Part 11, or EU Annex 11.
• Experience with pharmaceutical method validation, cleaning validation, or instrument qualification.
• Familiarity with Agile methodologies, including Scrum or SAFe.
• Familiarity with business-analysis practices and code-versioning concepts.

Work Details

• Onsite in Oceanside, California.
• Office and laboratory environment.
• May involve exposure to hazardous materials and chemicals.
• May require lifting up to 30 pounds.

Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.