Process Engineer

November 1

🌽 Illinois – Remote

Although this job is listed in Illinois, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷🏻‍♀️ Engineer

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Kneat Solutions

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SaaS • Compliance • Biotechnology

Kneat Solutions is a company that specializes in providing cutting-edge e-validation software designed to streamline and digitize validation processes across various industries, with a particular focus on the life sciences sector. Their software solutions are used globally by over 65,000 users, including 8 of the world's top 10 life sciences companies, to replace paper-based systems and ensure compliance with Good Manufacturing Practice. Kneat's platform supports a range of validation types including computer system validation, equipment validation, and process validation, helping industries achieve digital transformation and significant cost savings. Their technology has been notably utilized by Takeda, a leading biopharmaceutical company, to enhance efficiency and traceability in validation processes.

201 - 500 employees

☁️ SaaS

📋 Compliance

🧬 Biotechnology

📋 Description

• Lead customer projects from planning through to delivery, ensuring quality and compliance. • Translate customer processes into digital workflows using validation software. • Act as the main technical contact for assigned projects, supporting both customers and internal teams. • Contribute to internal documentation, training, and process improvements. • Represent Kneat within customer organisations, building strong relationships, and acting as a trusted advisor. • Engage with customer stakeholders (remotely and/or onsite) to understand business objectives and influence decision makers. Providing ongoing technical and strategic guidance to maximise customer value. • Communicate clearly with stakeholders and support knowledge sharing across teams. • Apply strong understanding of validation principles and industry standards to project work. • Deliver training and guidance to internal and external users on platform functionality. • Support onboarding and mentorship of junior team members. • Influencing executive stakeholders and supporting commercial conversations.

🎯 Requirements

• Bachelor’s degree in Engineering, Science, or a related field. • Typically a minimum of 3–5 years of experience in a regulated industry (e.g. life sciences, pharma, medical devices), with flexibility based on qualifications and project exposure. • Strong knowledge of validation practices such as CSV/CSA, CQV, or Process Validation. • Familiarity with regulatory frameworks such as GAMP, ICH, or 21 CFR. • Excellent communication and organisational skills. • Interest in software and digital tools, with a willingness to learn about SaaS platforms. • Ability to manage multiple projects independently and deliver to deadlines.

🏖️ Benefits

• A fantastic culture, team, and energy. • Competitive compensation. • Comprehensive benefits package. • Flexible work arrangements. • Training and professional development.