Process Engineer - North Carolina US Remote

Kneat•North Carolina, NC

8d•Remote

About The Position

Process Engineer – North Carolina, US - Remote Kneat enables regulated organisations to move from paper-based validation to intelligent, digitised, paperless solutions. Our purpose-built software platform, Kneat Gx, launched in 2014 after eight years of intensive development, is now the world’s most advanced validation software. It is trusted by leading Life Sciences companies to revolutionise the speed, precision, transparency, and intelligence of validation processes. What we’re looking for As Kneat continues to expand, we are looking for an enthusiastic Process Engineer to join our Operations department. Position overview 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. The position may also involve onsite assignments at customer locations as required. The position offers opportunities for deeper customer engagement, strategic alignment, and acting as the voice of Kneat within customer organizations. 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

Experience in consulting or onsite customer delivery.
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.
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.