About The Position

Kneat enables regulated organizations to move from paper-based validation to intelligent, digitized, paperless solutions. And we do it through the ongoing development of a powerful, purpose-built software platform. In 2014, after eight years of intensive software development, we launched Kneat Gx—the world’s most advanced validation software to help revolutionize the speed, precision, transparency, and intelligence of validation in the Life Sciences sector. Our solution is now used by some of the world’s leading Life Sciences companies. As Kneat continues to expand, we are looking for an enthusiastic Process Engineer to join our Operations department. This role will be remote in nature and based in the United States. Reporting to our Process Engineering Manager the Process Engineer will lead the delivery of digital validation solutions and process improvement initiatives for our life sciences customers. The successful candidate will lead implementation project execution, collaborate with cross-functional teams, and engage with customers to ensure high-quality outcomes. We are seeking someone with a strong background in validation engineering or life sciences who is curious about SaaS platforms and eager to work at the intersection of regulated processes and digital innovation to ensure our customers derive maximum value from the Kneat Gx platform. You’ll work directly with customers, manage project delivery, and contribute to continuous improvement across tools and practices. If this sounds like you, we want to hear from you!

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.

Nice To Haves

  • Postgraduate qualification (Masters) in Engineering, Validation, Project Management or related field.
  • Experience with digital validation platforms or SaaS tools (Kneat Gx, SAP, BMRAM, Trackwise, etc.).
  • A proactive mindset and interest in continuous improvement.
  • Project Management experience.
  • PMP certification is a significant bonus.

Responsibilities

  • 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.
  • 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.

Benefits

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