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18 results (2 new)

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Process Validation Engineer

Katalyst Healthcares and Lifesciences

Indianapolis, Indiana • Today

Full-time

Process Validation Engineer

INCOG BioPharma Services

Fishers, Indiana • Today

Full-time

Senior Validation Engineer

INCOG BioPharma Services

Fishers, Indiana • Today

Full-time

CQV Engineer - Commissioning, Qualification & Validation

PACIV

Indianapolis, Indiana • Today

Full-time

Senior Engineer, Process Validation

Danaher Corporation

Remote • Today

Full-time

USD 100,000.00 - 130,000.00 per year

Sr AI Validation Engineer

Cloud Destinations LLC

Remote • 2d ago

Easy Apply

Contract

$80 - $90

SKU Qualification Lead Engineer/Hardware Validation Engineer

Galactic Minds Inc.

Remote • 4d ago

Easy Apply

Full-time, Third Party

Depends on Experience

Staff Systems Engineer - Release Strategy & Validation

Torc Robotics

Remote or Ann Arbor, Michigan • Today

Full-time

USD 168,800.00 - 202,600.00 per year

Post-Silicon Systems Software Validation Engineer

Arrow Electronics, Inc.

Remote or California • Today

Full-time

USD 87,400.00 - 165,000.00 per year

Integration Validation Engineer- VHA Finance

HigherEchelon

Remote • Today

Full-time

Data Validation Engineer

GlobalLogic Inc.

Remote • 25d ago

Easy Apply

Full-time

100000 - 110000

Engineer Pharma Validation

Medline Industries, LP

Remote • Today

Full-time

USD 73,000.00 - 110,000.00 per year

Technical Lead - Systems Engineering, Validation and Verification, T56/501K and Helicopters Programs

Rolls Royce

Indianapolis, Indiana • Today

Full-time

USD 126,694.00 - 205,878.00 per year

Technical Lead - Systems Engineering, Validation and Verification, T56/501K and Helicopters Programs

Rolls-Royce Corporation

Indianapolis, Indiana • Today

Full-time

USD 126,694.00 - 205,878.00 per year

Regression and Production Validation Analyst

Teleperformance USA

Indianapolis, Indiana • Today

Full-time

Generative AI Scientist - (Model Risk & Validation)

Cotiviti

Remote • Today

Full-time

USD 110,000.00 - 130,000.00 per year

Sr Generative AI Scientist II - (Model Risk & Validation)

Cotiviti

Remote • Today

Full-time

USD 145,000.00 - 170,000.00 per year

Data Center Infrastructure Validation - Innovation Lead

EPRI

Remote or Washington, District of Columbia • Today

Full-time

USD 185,000.00 - 200,000.00 per year

Job Details

Skills

Management
Collaboration
Manufacturing
Science
IQ
OQ
PQ
Documentation
Communication
Conflict Resolution
Problem Solving
Computerized System Validation
Mapping
GMP
Good Manufacturing Practice
Regulatory Compliance
Corrective And Preventive Action
Change Control

Summary

Job Description:
We are seeking a Process Validation Engineer to support validation and qualification activities in a GMP-regulated manufacturing environment. The ideal candidate will have experience with process validation, equipment qualification, CSV, temperature mapping, and regulatory compliance.
Responsibilities:

Execute process validation and equipment qualification activities (IQ, OQ, PQ, PPQ).
Develop, review, and maintain validation protocols and reports.
Support Computer Systems Validation (CSV) activities.
Perform temperature mapping studies and analyze validation data.
Utilize Kneat or similar electronic validation management systems.
Support commissioning, qualification, and validation (CQV) projects.
Investigate deviations and support CAPA and change control activities.
Ensure compliance with GMP, FDA, and regulatory requirements.
Collaborate with Engineering, Manufacturing, Quality, and Regulatory teams.

Requirements:

Bachelor's degree in Engineering, Science, or a related field.
Experience in process validation, equipment qualification, or validation engineering.
Knowledge of IQ/OQ/PQ and validation lifecycle activities.
Familiarity with CSV principles and regulatory requirements.
Experience with Kneat, Ellab, or similar validation tools is preferred.
Understanding of GMP/cGMP regulations.
Strong documentation, communication, and problem-solving skills.

Preferred Skills:

Process Validation.
Equipment Qualification.
CSV (Computer Systems Validation).
Temperature Mapping.
Kneat.
Ellab Systems.
GMP/cGMP Compliance.
CAPA and Change Control.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 32d36eec3cb739cace844fd893d75867
Posted 30+ days ago

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Senior Validation Engineer

Fishers, Indiana

•

Today

Description INCOG BioPharma is seeking a highly motivated Senior Validation Engineer with validation expertise to join our team. The Senior Validation Engineer is a key individual contributor role within the INCOG BioPharma Validation Department. The Senior Validation Engineer is responsible for understanding and implementing validation requirements for a sterile injectables manufacturing facility. The ideal candidate has subject matter expertise and practical experience in qualification and va

Full-time

Process Validation Engineer

Fishers, Indiana

•

Today

Description TSMS - Process Validation Engineer The Technical Services and Manufacturing Sciences (TSMS) Process Validation Engineer will be responsible for supporting all facets of Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will provide technical support to ensure robust and reliable production processes are established and maintained. This position wil

Full-time

CSV Engineer

New Jersey

•

Today

Job Description: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer

Full-time

Engineer Pharma Validation

Remote

•

Today

Job Summary Responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. Assist in authoring and executing protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results within a controlled environment. Responsible for managing and or performing reval

Full-time

USD 73,000.00 - 110,000.00 per year

Job Details

Skills

Management
Collaboration
Manufacturing
Science
IQ
OQ
PQ
Documentation
Communication
Conflict Resolution
Problem Solving
Computerized System Validation
Mapping
GMP
Good Manufacturing Practice
Regulatory Compliance
Corrective And Preventive Action
Change Control

Summary

Execute process validation and equipment qualification activities (IQ, OQ, PQ, PPQ).
Develop, review, and maintain validation protocols and reports.
Support Computer Systems Validation (CSV) activities.
Perform temperature mapping studies and analyze validation data.
Utilize Kneat or similar electronic validation management systems.
Support commissioning, qualification, and validation (CQV) projects.
Investigate deviations and support CAPA and change control activities.
Ensure compliance with GMP, FDA, and regulatory requirements.
Collaborate with Engineering, Manufacturing, Quality, and Regulatory teams.

Requirements:

Bachelor's degree in Engineering, Science, or a related field.
Experience in process validation, equipment qualification, or validation engineering.
Knowledge of IQ/OQ/PQ and validation lifecycle activities.
Familiarity with CSV principles and regulatory requirements.
Experience with Kneat, Ellab, or similar validation tools is preferred.
Understanding of GMP/cGMP regulations.
Strong documentation, communication, and problem-solving skills.

Preferred Skills:

Process Validation.
Equipment Qualification.
CSV (Computer Systems Validation).
Temperature Mapping.
Kneat.
Ellab Systems.
GMP/cGMP Compliance.
CAPA and Change Control.

Dice Id: 91116760
Position Id: 32d36eec3cb739cace844fd893d75867
Posted 30+ days ago

Fitment

Dice Job Match Score™

📋 Comparing job requirements...

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Senior Validation Engineer

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Process Validation Engineer

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CSV Engineer

New Jersey

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Engineer Pharma Validation

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