Kneat Solutions

Making validation easier, faster, and smarter for Life Sciences

Process Engineer

EngineerEngineerFull TimeRemoteTeam 201-500H1B No SponsorCompany SiteLinkedIn

Location

North Carolina

Posted

57 days ago

Salary

Not specified

Bachelor Degree3 yrs expEnglishPMP

Job 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.

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

Benefits

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

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