Validation Engineer

Haumiller Engineering Co.

$70K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 2-year technical degree in engineering or equivalent work experience
  • Minimum of 3 years' experience in technical documentation writing
  • Proficient in developing technical documents and reading blueprints
  • Familiarity with LEAN manufacturing and 6 Sigma concepts preferred
  • ISO experience is a plus

Responsibilities

  • Develop and execute test cases for DQ/IQ/OQ/PQ protocols
  • Assist with FAT and SAT C&Q activities with customers
  • Collaborate on various technical documentation including specifications and manuals
  • Write and execute test cases to ensure machine functionality and quality
  • Develop and maintain documentation in Kneat Gx
  • Conduct risk assessments and failure mode effects analysis (FMEA)
  • Create technical construction files for CE machinery

Benefits

  • Medical insurance
  • Dental insurance - employer paid
  • Vision insurance - employer paid
  • Short and long-term disability - employer paid
  • Basic life and AD&D - employer paid
  • 401(k) with company contribution
  • Pension plan
  • Employee Stock Ownership Program (ESOP)
  • Paid time off
  • Tuition reimbursement
  • Wellness reimbursement
  • 8 paid holidays
Full Job Description
Validation Engineer

We are seeking an experienced Validation Engineer for our Belvidere, IL facility. The Validation Engineer is responsible for developing, maintaining and testing, commissioning and qualification (C&Q) documentation for new and existing machinery.

This position is 100% onsite and based in our Belvidere, IL facility. Depending on workload, this position may require occasional travel to work at our South Elgin, IL location.

What You Will Do:
• Develop documentation and execute test cases for DQ/IQ/OQ/PQ protocols complying with cGMP
• Assist with FAT and SAT C&Q activities with customers
• Collaborate with internal & external team members to write documentation that includes the: Functional Design Specification, Software Design Spec, Hardware Design Spec, Configuration Spec, Vision Design Spec, Owner's Manual, Operator-Tech Manual & PowerPoint presentations, Machine Task Instructions, RIT BOM, spare parts lists & other documentation as specified by our customers
• Write & execute test cases to verify machine function, quality control measures & performance
• Develop & update documentation in Kneat Gx
• Conduct and document risk assessments & failure mode and effects analysis (FMEA)
• Develop Technical construction files for CE machinery

What You Will Bring:
• 2-year technical degree with emphasis in engineering or equivalent combination of education coursework, internships and work experience in manufacturing
• Minimum of 3 years' experience writing technical documentation
• Ability to develop technical documents and read blueprints
• Experience with LEAN manufacturing and 6 Sigma Concepts and tools preferred. ISO experience a plus

Haumiller Engineering compensation decisions are based on relevant factors such as job-related skills, experience and education or training. Should an offer for employment be made, individual qualifications will be considered.

What We Offer:
• Medical insurance
• Dental insurance - employer paid
• Vision Insurance - employer paid
• Short and Long-term disability - employer paid
• Basic Life and AD&D - employer paid
• Voluntary Life insurance
• 401(k) with company contribution
• Pension plan
• Employee Stock Ownership Program (ESOP)
• Paid time off
• Flexible Spending Account (FSA)
• Health Savings Account (HSA)
• Tuition reimbursement
• Employee Assistance Program (EAP)
• Wellness Reimbursement
• 8 paid holidays

Monday - Thursday 7 am - 4 pm
Friday 7 am - 12 pm

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