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Software engineer (pharma)

Stein (Rheinfelden)
QPS Engineering AG
Software Ingenieur
Inserat online seit: 7 Mai
Beschreibung

Join QPS Engineering AG as a Software Engineer (Pharma) Become part of a future-oriented team driving digital innovation in pharmaceutical manufacturing. In this role, you will design, implement, and validate software systems that support GMP-compliant production processes, ensuring data integrity, system reliability, and regulatory compliance.

You’ll work on high-impact projects in close collaboration with cross-functional teams and bring your technical expertise to the core of pharmaceutical digitalization. If you are passionate about software engineering and have at least 2 years of experience in the field, we look forward to your application!

Job Title:

Software Engineer (Pharma)

Type:

Full-time, Hybrid

Experience:

Minimum 2 years

What We Offer At QPS Engineering AG, you’ll play a key role in shaping the digital future of pharmaceutical operations. We value innovation, interdisciplinary teamwork, and technical precision.

You’ll work alongside passionate professionals on meaningful projects that directly contribute to patient safety and product quality.

Opportunities for professional development and certifications

A supportive and inclusive work culture

Responsibilities

Designing, developing, and integrating software systems for GMP-regulated production environments

Supporting the creation of system specifications, user requirement specifications (URS), and functional design specifications (FDS)

Implementing and validating software solutions such as MES, LIMS, SCADA interfaces, and database applications

Ensuring compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and other pharmaceutical software validation standards

Collaborating with cross-functional teams to define and execute qualification and validation strategies (IQ/OQ/PQ)

Managing risk assessments related to software systems, including cybersecurity and data integrity topics

Providing internal training and documentation on validated software applications

Preferred Qualifications

Bachelor’s or Master’s degree in Computer Science, Software Engineering, or a related technical field

Minimum of 2 years of experience in software development or integration within the pharmaceutical, biotech, or life sciences sector

Strong knowledge of GMP, GAMP 5, and regulatory requirements for computerized systems

Familiarity with manufacturing IT/OT systems (e.g., MES, LIMS, SCADA, ERP integrations)

Fluent in German and English (written and spoken)

Excellent analytical thinking and structured approach to software lifecycle documentation

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