Validation Engineer – Pharma cGMP & Sterile Systems

Yoh, A Day & Zimmermann Company; Noblesville (IN); On-site; USD 80,000 - 86,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account (HSA)

Life & Disability Insurance

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Referral Bonus Programs

Certification and training

Equal Opportunity Employer

Job summary

Yoh is seeking a Validation Engineer for a pharmaceutical manufacturing client in Noblesville, IN. The role focuses on hands-on validation activities for CIP systems, sterile processes, and associated utilities within a GMP environment.

Responsibilities include leading validation lifecycle activities, coordinating cross-functionally, and producing validation reports. Familiarity with temperature mapping tools and regulatory requirements is required. Competitive benefits apply.

Qualifications

• Bachelor's degree in life sciences or engineering required; experience may substitute for degree.
• 3+ years of relevant validation experience required.
• 2+ years of validation experience with sterile processes required.
• Working knowledge of global cGMPs.

Responsibilities

• Lead validation activities across URS, criticality assessments, risk assessments, FAT/SAT, IQ/OQ/PQ, CSV, CV, PV, and re-qualifications for equipment, facilities, and utilities.
• Coordinate with R&D, Operations, lab and Engineering to estimate resources, schedules and risks.
• Create validation summary reports, including exceptions or deviations as needed.
• Generate and review Change Control documents and site validation documentation.
• Support internal and external audits with expert insights and issue resolution.

Skills

Project management

Cross-functional collaboration

Validation lifecycle

cGMP knowledge

Documentation

Audit support

Temperature mapping equipment

Education

Bachelor's degree in life sciences or engineering

Tools

Kaye Validator

ValProbe

Ellab

Job description

Yoh is seeking a Validation Engineer for a pharmaceutical manufacturing client in Noblesville, IN. The role focuses on hands-on validation activities for CIP systems, sterile processes, and associated utilities within a GMP environment.

Responsibilities include leading validation lifecycle activities, coordinating cross-functionally, and producing validation reports. Familiarity with temperature mapping tools and regulatory requirements is required. Competitive benefits apply.