Validation Engineer

Haumiller Engineering Co.

$80K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 2-year technical degree in engineering or equivalent experience
  • 3+ years of technical documentation writing experience
  • Proficient in developing technical documents and interpreting blueprints
  • Familiarity with LEAN manufacturing and Six Sigma preferred
  • ISO experience is a plus

Responsibilities

  • Develop and execute documentation for DQ/IQ/OQ/PQ protocols adhering to cGMP
  • Assist with FAT and SAT C&Q activities alongside customers
  • Collaborate to produce comprehensive technical documents including specifications and manuals
  • Write and execute test cases to validate machine functionality and performance
  • Update documentation in Kneat Gx software
  • Conduct risk assessments and FMEA
  • Create Technical construction files for CE machinery

Benefits

  • Medical insurance coverage
  • Employer-paid dental and vision insurance
  • Short and long-term disability coverage paid by employer
  • 401(k) plan with company contributions
  • Employee Stock Ownership Program (ESOP)
  • Pension plan
  • Tuition reimbursement for ongoing education
  • Wellness reimbursement
  • Paid time off including 8 holidays
  • Employee Assistance Program (EAP)
  • Flexible Spending Account (FSA) and Health Savings Account (HSA)
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 will 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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