Bioinformatics Pipeline Validation Engineer

Creative Solutions Services, LLC; San Diego (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Creative Solutions Services, LLC in San Diego, California is seeking a software engineer embedded in bioinformatics to help develop pipelines for NGS and PCR applications, within an FDA-regulated environment.

You will collaborate across teams, implement CI/CD, and adhere to best practices. Excellent communication and ability to translate complex architectures into practical designs are essential.

Experience with Python, cloud platforms, Docker/Kubernetes, and safety standards is preferred.

Qualifications

• B.S. Degree in Computational Biology, Computer Science, or field as outlined in the essential duties.
• Familiarity with the development of bioinformatics pipelines within Next Generation Sequencing and PCR applications.
• Familiarity with production software development lifecycle.
• Familiarity with best practices for software development (such as Git, agile, code reviews, CI/CD).
• Ability to effectively communicate software system designs.
• Excellent communication skills (both written and oral) with the ability to communicate complicated ideas and information effectively at all levels.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Experience with programming languages, ideally Python.
• Familiar with automated software testing, preferably in the context of medical devices software such as bioinformatics analysis pipelines.
• Familiarity with container orchestration concepts and systems, e.g. Docker, Kubernetes, etc.
• Familiar working with cloud platforms (AWS, GCP, Azure).
• Familiarity within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry, developing CFR 21 Part 11 and IEC 62304 compliant software.
• Familiarity with medical device requirements such as Quality System Regulation (21 CFR part 820) ISO 14971 Medical Device Risk Management, ISO 13485, etc. Work experience is strongly preferred.
• Familiarity with bioinformatics analysis pipeline frameworks.
• Familiarity with software related Cybersecurity risk management such as FDA Cybersecurity guidance, IEC27000 series, IEC 15408, etc. as well as software audits is a plus.
• Familiar with managing requirements in a validated RM tool such as JAMA, DOORS, etc.

Skills

Bioinformatics pipelines

Software development lifecycle

Communication of software designs

Written and spoken communication

CI/CD knowledge

Education

B.S. degree in Computational Biology/Computer Science or related field

Tools

Git

Agile

CI/CD

Docker

Kubernetes

AWS

GCP

Azure

Job description

Creative Solutions Services, LLC in San Diego, California is seeking a software engineer embedded in bioinformatics to help develop pipelines for NGS and PCR applications, within an FDA-regulated environment.

You will collaborate across teams, implement CI/CD, and adhere to best practices. Excellent communication and ability to translate complex architectures into practical designs are essential.

Experience with Python, cloud platforms, Docker/Kubernetes, and safety standards is preferred.