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Engineer

Engineer

SoTalentHickory, NC, US
16 hours ago
Job type
  • Full-time
Job description

2 days ago Be among the first 25 applicants

This range is provided by SoTalent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$88,000.00 / yr - $121,000.00 / yr

Join a global healthcare manufacturer dedicated to delivering high-quality therapies and technologies that improve outcomes across hospital, clinical, and home settings. Be part of a mission-driven organization focused on patient care and innovation.

About the Opportunity

Our client is seeking a skilled Validation Engineer to support critical system qualifications at a large-scale manufacturing site. This role plays a key part in ensuring that new and existing equipment, software, and facility systems meet industry standards and regulatory requirements.

You'll provide technical validation support for a wide variety of systems—from automated inspection and packaging lines to cleanroom environments and water purification setups. If you enjoy hands-on technical work, process improvement, and collaborating across functional teams, this is a great fit.

What You'll Do

  • Lead and support validation activities for facility systems, manufacturing equipment, and automation platforms in compliance with industry regulations and internal policies
  • Contribute to equipment and software qualification processes (IQ / OQ / PQ), including development of test plans and execution documentation
  • Perform and document validation activities for equipment and processes across a range of systems such as water purification, formulation equipment, automated visual inspection, and lab instruments
  • Apply knowledge of regulatory standards (e.g., 21 CFR Part 11, FDA Process Validation Guidance, USP Chapters) to ensure compliance
  • Participate in project planning and timeline execution during equipment upgrades, facility shutdowns, and maintenance windows
  • Work closely with engineering, IT, QA, manufacturing, and other stakeholders to coordinate validation needs
  • Troubleshoot validation-related issues and contribute to root cause analyses, non-conformance resolutions, and change control activities
  • Ensure computer system validation (CSV) aligns with software lifecycle protocols and data integrity standards
  • Translate technical details into clear documentation and validation reports for internal and regulatory purposes
  • Support continuous improvement initiatives and contribute to equipment commissioning as needed

Who You Are

  • Bachelor's degree in an Engineering discipline (e.g., Mechanical, Electrical, Chemical, Industrial, or Biomedical)
  • At least 3 years of experience in validation engineering or quality assurance within regulated industries such as pharmaceuticals, biotech, or medical devices
  • Experience with equipment, utility, and computer system validation; familiarity with industry protocols (IQ / OQ / PQ) and data integrity principles (ALCOA)
  • Skilled in interpreting system schematics, protocols, and technical documentation
  • Proficient with Microsoft Office applications; experience with tools like AutoCAD, E-Plan, Wonderware, or PLCs (e.g., Allen-Bradley) is a plus
  • Self-driven with strong problem-solving skills and attention to detail
  • Able to work independently and collaboratively across multi-site or cross-functional teams
  • Excellent written and verbal communication skills
  • Salary and Benefits

  • Salary Range : $88,000 – $121,000 annually (based on location, experience, and qualifications)
  • Additional Benefits Include :
  • Medical, dental, and vision coverage from day one
  • 401(k) with company match
  • Stock purchase plan
  • Paid parental leave and paid holidays
  • Tuition assistance
  • Generous paid time off and sick leave
  • Please note : This job posting is just a preview of the full scope of the position. A comprehensive job description is shared by a member of our team.

    Seniority level

  • Mid-Senior level
  • Employment type

  • Full-time
  • Job function

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    Engineer • Hickory, NC, US

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