Senior Validation Engineer

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Harba Solutions Inc. in Indianapolis seeks a Manufacturing Validation Specialist to lead qualification activities for equipment, utilities and facilities within a GMP environment.

You will develop validation plans, URS, risk assessments, qualification protocols (IQ/OQ/PQ), and FAT/SAT, then execute them on site while partnering with Engineering, Manufacturing and Quality to ensure compliant startup and ongoing qualification of systems.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or another technical discipline.
• Three or more years of experience performing validation or commissioning and qualification activities in a GMP-regulated manufacturing environment.
• Demonstrated experience authoring and executing qualification documentation such as URS, risk assessments, FAT/SAT, IQ/OQ/PQ, and validation reports.
• Hands-on experience qualifying manufacturing equipment, facilities, utilities, laboratory systems, or cleanroom environments.
• Understanding of sterile or aseptic manufacturing operations, including equipment used in pharmaceutical production.
• Experience with cleaning validation, controlled temperature unit qualification, or temperature mapping is highly desirable.
• Working knowledge of GMP documentation practices, deviations, CAPAs, investigations, and change management.
• Strong technical writing, problem-solving, and cross-functional communication skills.
• Comfortable working directly on the manufacturing floor during equipment startup, qualification, and production support activities.

Responsibilities

• Own validation and qualification activities for manufacturing equipment, utilities, facilities, and production support systems within a regulated pharmaceutical environment.
• Prepare and execute validation lifecycle documentation including validation plans, user requirements, risk assessments, qualification protocols, and final reports.
• Lead commissioning and qualification efforts for new equipment installations and manufacturing projects from planning through operational release.
• Perform and document FAT, SAT, IQ, OQ, and performance qualification testing while resolving issues identified during execution.
• Support qualification of sterile manufacturing equipment, cleanrooms, critical utilities, and environmental control systems.
• Execute cleaning validation activities, temperature mapping studies, and requalification efforts for existing manufacturing systems.
• Investigate deviations, support root cause analysis, and implement corrective actions through change controls and CAPA processes.
• Develop, revise, and maintain validation procedures, SOPs, and other GMP documentation.
• Partner with Engineering, Manufacturing, Quality, and equipment vendors to ensure successful startup and qualification of new systems.
• Provide validation support during internal audits, regulatory inspections, and continuous improvement initiatives.
• Coordinate multiple validation projects while tracking priorities, timelines, and deliverables.

Skills

Validation experience

GMP documentation

Technical writing

Root cause analysis

Cross-functional collaboration

Problem solving

On-floor experience

Education

Bachelor's degree in Engineering

Tools

URS writing tools

Change control system

CAPA system

Job description

• Own validation and qualification activities for manufacturing equipment, utilities, facilities, and production support systems within a regulated pharmaceutical environment.
• Prepare and execute validation lifecycle documentation including validation plans, user requirements, risk assessments, qualification protocols, and final reports.
• Lead commissioning and qualification efforts for new equipment installations and manufacturing projects from planning through operational release.
• Perform and document FAT, SAT, IQ, OQ, and performance qualification testing while resolving issues identified during execution.
• Support qualification of sterile manufacturing equipment, cleanrooms, critical utilities, and environmental control systems.
• Execute cleaning validation activities, temperature mapping studies, and requalification efforts for existing manufacturing systems.
• Investigate deviations, support root cause analysis, and implement corrective actions through change controls and CAPA processes.
• Develop, revise, and maintain validation procedures, SOPs, and other GMP documentation.
• Partner with Engineering, Manufacturing, Quality, and equipment vendors to ensure successful startup and qualification of new systems.
• Provide validation support during internal audits, regulatory inspections, and continuous improvement initiatives.
• Coordinate multiple validation projects while tracking priorities, timelines, and deliverables.

Preferred Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or another technical discipline.
• Three or more years of experience performing validation or commissioning and qualification activities in a GMP-regulated manufacturing environment.
• Demonstrated experience authoring and executing qualification documentation such as URS, risk assessments, FAT/SAT, IQ/OQ/PQ, and validation reports.
• Hands-on experience qualifying manufacturing equipment, facilities, utilities, laboratory systems, or cleanroom environments.
• Understanding of sterile or aseptic manufacturing operations, including equipment used in pharmaceutical production.
• Experience with cleaning validation, controlled temperature unit qualification, or temperature mapping is highly desirable.
• Working knowledge of GMP documentation practices, deviations, CAPAs, investigations, and change management.
• Strong technical writing, problem-solving, and cross-functional communication skills.
• Comfortable working directly on the manufacturing floor during equipment startup, qualification, and production support activities.