Process Engineer - North Carolina US Remote

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!

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.

Minimum qualifications

• 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.

What we offer you

At Kneat, we truly value ideas and collaboration so we’ve created an environment that builds, protects, and celebrates teamwork. Our strong culture is central to our continued success.

We offer programs and rewards that one would expect from a highly successful and growing technology company.

· A fantastic culture, team, and energy.

· Competitive compensation.

· Comprehensive benefits package.

· Flexible work arrangements.

· Training and professional development.

All applicants will need to fulfill the requirements necessary to obtain a background check.

Kneat is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to Equal Employment Opportunity (EEO) regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.

Reasonable accommodations may be made to enable qualified individuals with disabilities or special needs to perform these essential functions. If you have a disability or special need that requires accommodation to complete this application form, please contact us at +353 (0)612 038 26 (Ext 2004) or email us at [email protected] for assistance.