Senior Validation Engineer

Harba Solutions Inc.; Indianapolis, Northern (IN, KY); Hybrid; USD 100,000 - 150,000; Full time

Benefits offered by this job

Paid vacation (tenure‑based) and paids

11 observed holidays

401(k) with company match up to 3.5%,

Health & wellness plans

FSA and HSA programs

Dental & vision care

Job summary

Harba Solutions Inc. in Indianapolis is hiring a Senior Validation Engineer to lead qualification and validation activities for a sterile injectables facility.

The role partners with internal customers on client projects, facility upgrades, capital expansion, and laboratory systems, influencing outcomes without direct reporting authority. The ideal candidate has 5–8 years in validation, GMP experience, a STEM degree, and hands-on SOP/work instruction development, risk assessment, and

Qualifications

• Bachelor’s degree or higher in a STEM discipline.
• 5–8 years of experience in Validation or a related discipline.
• 4+ years of GMP experience (or other regulated industry).
• Ability to work onsite.

Responsibilities

• Perform qualification activities on utilities, equipment, and laboratory systems — including clean utilities, autoclaves, washers, fillers, laboratory instruments, and controlled temperature units
• Interact with clients to provide validation support, including customer product launches and new equipment qualifications
• Support and provide validation oversight for capital expansion projects and build‑outs
• Own the development and modification of SOPs, Work Instructions, and guidelines for equipment validation policies, standards, procedures, and templates
• Review facility changes and provide input on re‑validation and re‑qualification of equipment
• Assess risks in processing steps related to equipment; develop and/or review validation requirements and design deliverables
• Engage cross‑functionally with Engineering and Operations to support validation and process improvement efforts
• Conduct validation qualifications per applicable protocols and identify protocol excursions
• Track industry trends in validation and regulatory expectations, proposing program updates as needed

Skills

Validation

GMP

Onsite work

Cross-functional collaboration

Education

Bachelor’s degree or higher in STEM

Tools

Computer System Validation

Cleaning Validation

VHP & Steam Sterilization

Job description

Are you a Validation Engineer looking for an exciting opportunity with an organization where you can make an impact on global health and wellness?

We are seeking a highly motivated Senior Validation Engineer with validation expertise to join our team. This is a key individual contributor role within our Validation Department, responsible for understanding and implementing validation requirements for a sterile injectables manufacturing facility. The ideal candidate has subject matter expertise and hands‑on experience in qualification and validation.

You’ll partner with internal customers to support client projects, facility upgrades, capital expansion projects, and laboratory systems — and will need a demonstrated ability to influence positive outcomes without direct reporting authority, while adapting to the evolving needs of a manufacturing environment.

Essential Job Functions:

• Perform qualification activities on utilities, equipment, and laboratory systems — including clean utilities, autoclaves, washers, fillers, laboratory instruments, and controlled temperature units
• Interact with clients to provide validation support, including customer product launches and new equipment qualifications
• Support and provide validation oversight for capital expansion projects and build‑outs
• Own the development and modification of SOPs, Work Instructions, and guidelines for equipment validation policies, standards, procedures, and templates
• Review facility changes and provide input on re‑validation and re‑qualification of equipment
• Assess risks in processing steps related to equipment; develop and/or review validation requirements and design deliverables
• Engage cross‑functionally with Engineering and Operations to support validation and process improvement efforts
• Conduct validation qualifications per applicable protocols and identify protocol excursions
• Track industry trends in validation and regulatory expectations, proposing program updates as needed

Requirements:

• Bachelor’s degree or higher in a STEM discipline
• 5–8 years of experience in Validation or a related discipline
• 4+ years of GMP experience (or other regulated industry)
• Ability to work onsite

Preferred:

• Master’s degree or higher
• Computer System Validation experience
• Cleaning Validation experience
• VHP & Steam Sterilization experience

Benefits:

• Paid vacation (tenure‑based) and paid sick time
• 11 observed holidays
• 401(k) with company match up to 3.5%, vested immediately
• Choice of health & wellness plans
• FSA and HSA programs
• Dental & vision care