Pharma Validation Engineer – Equipment, HVAC & Process

Pioneer Data Systems; Valley Falls (KS); On-site; USD 65,000 - 90,000; Full time

Job summary

Pfizer is seeking a Validation Engineer to support equipment, HVAC, utility and process qualification within a pharmaceutical setting. The role involves writing system impact assessments, oversight during shutdowns, and IQ/OQ/PQ activities, with potential weekend or night shifts.

The ideal candidate has a BS/BA in a science or engineering field and at least four years of pharmaceutical validation experience, along with knowledge of ICH and related guidelines. On-site weekly travel is required.

Qualifications

• Knowledge of ICH and other regulatory guidelines; demonstrated ability to interpret and apply these guidelines to document writing

Responsibilities

• Schedules and executes validations/qualifications per SOPs and regulatory guidelines.
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Executes equipment, facility, utility and computer system validation studies including protocol preparation, scheduling, execution, data analysis and final report drafting.
• Oversee and assist engineers and/or technicians with their assigned projects.
• Provide technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 parts 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations.
• Thorough understanding of risk-based validation and industry best practices

Skills

Regulatory guidelines knowledge

Education

BS/BA in science/engineering

Job description

Pfizer is seeking a Validation Engineer to support equipment, HVAC, utility and process qualification within a pharmaceutical setting. The role involves writing system impact assessments, oversight during shutdowns, and IQ/OQ/PQ activities, with potential weekend or night shifts.

The ideal candidate has a BS/BA in a science or engineering field and at least four years of pharmaceutical validation experience, along with knowledge of ICH and related guidelines. On-site weekly travel is required.