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Kneat Solutions · 5 hours ago

Process Engineer - North Carolina US Remote

United States

Full-time

Remote

Mid Level

3+ years exp

Kneat Solutions is a company that enables regulated organizations to transition from paper-based validation to intelligent, digitized solutions. They are seeking a Process Engineer to lead the delivery of digital validation solutions and process improvement initiatives for life sciences customers, ensuring high-quality outcomes through collaboration and project management.

ComplianceSaaSSoftware

Growth Opportunities

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

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

Qualification

Validation practicesRegulatory frameworksProject ManagementSaaS platformsDigital validation toolsContinuous improvementCommunicationOrganisational skills

Required

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