Senior Validation Engineer - Pharma Equipment & Compliance

Fagron Nederland BV; Wichita (KS); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, vision and dental insurance

Health Savings Account (HSA)

Job summary

Fagron US is seeking a qualified validation professional to validate and document pharmaceutical manufacturing equipment, calibrations and related computer-based control systems. Responsibilities include validating PV and stability studies, interpreting PI&Ds and electrical drawings, and ensuring compliance with FDA/cGMP requirements.

The ideal candidate has 3–5 years in metrology/validation, familiarity with 21 CFR Part 11 and GMP guidelines, and strong communication skills.

Qualifications

• BS degree in Mechanical, Industrial, Automation, or Chemical Engineering or equivalent pharmaceutical experience.
• 3–5 years in metrology and validation of pharmaceutical manufacturing equipment.
• Experience with regulatory inspections and defending work.
• Knowledge of injectable pharma industry; sterile compounding preferred.
• Experience in cGMP environments per FDA/EMA/ICH.

Responsibilities

• Prepare, execute and summarize validation protocols and reports.
• Read and interpret PI&Ds, electrical and pneumatic drawings.
• Understand PC and PLC-based control systems hardware/software.
• Comply with FDA and cGMP guidelines related to CVQ and data integrity.
• Participate in PV and stability studies, utilities and equipment validations.
• Maintain balance between work and personal life while delivering results.

Skills

Metrology experience

Regulatory inspections

cGMP knowledge

21 CFR Part 11

Quality systems

GMP knowledge

21 CFR Part 210/211

Prioritization

Communication skills

Education

Bachelor of Science in Engineering

Tools

Kaye AVS Validator

Job description

Fagron US is seeking a qualified validation professional to validate and document pharmaceutical manufacturing equipment, calibrations and related computer-based control systems. Responsibilities include validating PV and stability studies, interpreting PI&Ds and electrical drawings, and ensuring compliance with FDA/cGMP requirements.

The ideal candidate has 3–5 years in metrology/validation, familiarity with 21 CFR Part 11 and GMP guidelines, and strong communication skills.