FDA Validation Engineer Job at JR Automation (Liberty, Greenville)

FDA Validation Engineer

JR Automation, a Hitachi Group Company, is driven to deliver customer success wo...

Location

United States , Nashville

Salary:

Not provided

JR Automation

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Electrical Engineering or equivalent experience, calculated as two (2) years of relevant work experience for each year of academic study
3+ years performing validation activities in a Medical Device or Life Science environment preferred
Experience working in a GAMP 5 based validation model
Current or prior JR Automation experience, or experience in the automation industry is strongly preferred
Ability to understand electrical/pneumatic schematic drawings
Experience with PLC Control Systems preferred
Debugging skills preferred

Job Responsibility

Provide validation experience and guidance during equipment design, software design, build, debug, qualification and improvement phases of a project
Develop pertinent document templates tailored to customer SOP’s
Write overall project quality (validation scope) plans and validation summary reports
Organize, guide, and write requirement specifications
Oversee, execute and review qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies
Travel up to 25% to customer sites & other JR locations
Train and mentor 1-2 team members as directed

Validation Engineer

We are currently seeking a Validation Engineer to join our team in Pittsburgh, P...

Location

United States , Pittsburgh

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Life Sciences, or related field
4+ years of experience in validation within healthcare, pharma, or medical devices domain
4+ years of strong knowledge of CSV (Computer System Validation)
4+ years of strong knowledge of FDA regulations & ISO standards (e.g., ISO 13485)
4+ years of experience with validation tools and documentation practices
Good understanding of SDLC and Agile methodologies
Strong analytical, documentation, and communication skills

Job Responsibility

Develop, review, and execute validation deliverables including Validation Plans (VP), User Requirement Specifications (URS), Functional/Design Specifications (FS/DS), IQ/OQ/PQ protocols and reports
Perform computer system validation (CSV) for healthcare/medical applications
Ensure compliance with FDA 21 CFR Part 11, GAMP 5, HIPAA, and other applicable regulations
Conduct risk assessments and validation impact analysis
Collaborate with cross-functional teams (QA, IT, Regulatory, Business)
Support audit readiness and participate in internal/external audits
Manage deviations, CAPA, and change controls related to validation activities
Maintain validation documentation lifecycle in accordance with SOPs
Provide validation support for software upgrades, implementations, and integrations

Fulltime

Validation Engineer

The Validation Engineer is responsible for executing and maintaining validation ...

Location

United States , Wichita

Salary:

Not provided

Fagron

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering or a scientific discipline (or equivalent experience)
2–5 years of validation experience in pharmaceutical, sterile manufacturing, or 503B compounding
Strong understanding of aseptic processing, cleanroom classification, equipment/utility systems (HVAC, WFI/PW, compressed gases), and sterile filling operations
Experience with cGMP documentation, risk assessments, change control, and CAPA systems
Proficient in technical writing, data analysis, and cross-functional collaboration
Ability to work in a fast-paced, highly regulated environment with strong attention to detail

Job Responsibility

Develop, execute, and maintain validation documents (IQ/OQ/PQ, PPQ, APS, CCIT, cleaning validation, equipment qualification, utility qualification)
Ensure validation activities comply with FDA 503B guidance, cGMPs (21 CFR Parts 210/211), and industry standards (USP <797>/<800>, ISPE, PDA)
Serve as validation SME for operations, engineering, quality, and new product introduction
Conduct and document validation-related investigations, including deviations, OOS, OOT, change controls, impact assessments, and CAPA root-cause analyses
Manage periodic review, revalidation, and continued process verification activities
Maintain calibration and preventative maintenance compliance for critical equipment and utilities
Support introduction of new equipment, closed systems, and aseptic technologies (e.g., single-use systems, isolators, automated filling systems)
Analyze validation data using appropriate statistical tools and prepare clear technical reports
Participate in regulatory inspections and defend validation lifecycle documentation
Stay current with regulatory expectations, emerging risks, and sterile compounding best practices

What we offer

competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry

Fulltime

Process Validation Engineer

Reporting to the Senior Manager process Validation, the Process Validation Engin...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments
Proficient in the development and execution of PPQs
Review commissioning, qualification and validation related system lifecycle documentation
Combination of equipment qualification, process validation, or cleaning validation is acceptable
QA pharmaceutical experience also preferred
Validation experience with the following is highly preferred: Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization, Steam Sterilization, data analysis and statistics
Engagement and knowhow with regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes
Bachelor of Science degree in Chemical Engineering, Biochemistry, Biology or related scientific discipline required with a minimum of 7 – 10 years of Pharmaceutical industry experience or combination of work experience in Validation, QA, MFG, MTS, Process Development or Engineering
Highly organized professional who is accustomed to working in a result oriented-focused, dynamic CMO environment
Professional and collaborative team player must have excellent interpersonal skills

Job Responsibility

Develop and support the detailed project plans and timelines for the execution of process validation activities
Prepare validation & change control documentation, including protocols, summary reports, etc.
Author Process Performance Qualification/ verification validation plans
Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring, perform activities for lot release
Participate in client and Regulatory Audits
Work on CAPA and QS with minimal oversight to achieve timely results
Assist with determining impact of change control on qualified process and aseptic operations
Work closely with other validation department personnel and cross-functionally with MTS, Manufacturing, Engineering, QC, Quality Assurance, and project management to achieve all project deliverables
Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation
Perform all functions associated with process validation support

Fulltime

Senior Validation Engineer

We are seeking a highly skilled Senior Validation Engineer to support the valida...

Location

United States , Rockford

Salary:

97280.00 - 107008.00 USD / Year

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline
advanced degree preferred
Minimum of 5–8 years of validation experience in the medical device, pharmaceutical, or biotech industry
Strong knowledge of FDA regulations, ISO 13485, ISO 14971, and GAMP 5 principles
Hands-on experience with equipment and process validation on assembly lines (manual, semi-automated, or fully automated)
Proficient in risk management and statistical tools (e.g., Minitab, JMP)
Excellent technical writing and communication skills
Ability to manage multiple projects and timelines in a dynamic manufacturing environment

Job Responsibility

Lead and execute validation lifecycle activities including IQ/OQ/PQ for manufacturing equipment, utilities, and automated assembly lines
Develop and execute validation master plans, protocols, and reports in compliance with internal procedures and regulatory expectations
Provide validation support for process changes, new product introductions (NPIs), and customer tech transfers
Apply risk-based approaches (e.g., per ISO 14971) to validation strategy and justification
Utilize statistical methods to define sampling plans and acceptance criteria for validation studies
Support cleaning validation and verification activities for equipment used in medical device production
Collaborate with cross-functional teams, including Manufacturing, Quality, Engineering, and Regulatory Affairs
Review and approve equipment specifications, process FMEAs, URS, and validation documentation
Conduct gap assessments and remediation planning for existing validation documentation when required
Ensure all validation activities meet the standards set by FDA 21 CFR Part 820, ISO 13485, and customer requirements

What we offer

5% MBP annual performance bonus eligibility
paid time off
health insurance coverage (including dental and vision)
flexible spending account
401(k)

Fulltime

Verification and Validation Engineer

The role of V&V Engineer is to make technical contributions in understanding sys...

Location

India , Bangalore

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
5 to 8 years of experience in Verification and validation testing of Software and hardware
Relevant technical testing/reliability experience in electro-mechanical, electrical, or software testing
Understanding of hardware schematic diagrams and debugging tools like IC5000, CAN Analyzer, Trace 32, Keil IDE, PEAK analyzer, Oscilloscope
Any scripting knowledge like python, shell etc. Good programming knowledge and basic understanding of Embedded programming
Understanding of modeling (MATLAB, Simulink etc.)
Test framework development and test harness development knowledge
Knowledge of hardware in loop and software in loop testing
An understanding of test methods and processes as well as the methods used to verify products in the realms of software, mechanical, electrical, functional and environmental testing environments
Experience in - writing system, subsystem-level and module level verification and validation plans, procedures, Test Execution and Test report generation

Job Responsibility

Review, Author, Execute, perform, summarize, report out verification & validation test activities of components to a full system device
Support compliance/ closure of Regulatory and Quality requirements before completing Design Outputs/ Program Deliverables
Participate in the development of Verification & Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry best practices
Lead the qualification of lab area, productivity improvement efforts, including testing, building fixtures, calibration and data collection
Diagnose, isolate and investigate problem reports. Drive product improvements and/or bug fixes
Ensure good documentation and Good Manufacturing practices are followed in the Verification and Validation Process
Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives
Deep knowledge in test automation tools and realizing test automation suite
Work closely with the auditees to understand the details and support all relevant objective evidence
Adheres to Baxter Quality Management system & supports the quality audits

What we offer

Apoyo a las padres
Educación continua/ Desarrollo profesional
Salud de los empleados y Beneficios de bienestar
Tiempo libre pagado
2 días al año para ser voluntario

Fulltime

Quality Engineer - Validation

The Quality Validation Engineer is responsible for planning, coordinating and ma...

Location

United States , Buffalo Grove, Illinois

Salary:

85000.00 - 105000.00 USD / Year

Nemera

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Science or related field
3+ years' of experience in a Quality position strongly preferred
Experience in the Medical Device industry strongly preferred (ISO13485)
Experience with technical writing, IQ/OQ/PQ is preferred
Experience with equipment validation is preferred
Experience working onsite in Manufacturing is strongly preferred
Excellent communication skills with the ability to understand, read, write and speak English required
Must have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge
Six-sigma experience, training or certification preferred
Intermediate level computer skills, including Microsoft Office applications required

Job Responsibility

Assists the Quality Manager in coordinating and executing objectives throughout the company
Identify and coordinate resolution of system inefficiencies
Coordinate and manage the execution of validations and creation of written protocols
Coordinate and manage the execution of change control activities
Assess results of Customer Complaint investigations and Corrective Actions
Utilize CAPA problem solving techniques
Develop and analyze statistical data
Evaluate compliance using relevant information and individual judgment
Develop product specifications for existing products
Plan, coordinate, and manage assigned Supplier Quality evaluations

Fulltime

Computer System Validation Engineer

The Computer System Validation (CSV) Engineer II will ensure compliance of compu...

Location

United States , Irvine

Salary:

95000.00 - 110000.00 USD / Year

ALTEN Technology USA

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Computer Science, or related field
2–4 years of experience in Computer System Validation within a pharmaceutical or regulated industry
Hands-on experience with Manufacturing Execution Systems (MES) and iFIX SCADA system qualification
Strong understanding of GAMP 5, FDA, and EU GMP guidelines
Familiarity with cleanroom operations and manufacturing equipment integration
Excellent technical writing and documentation skills
Ability to work independently and manage multiple validation projects simultaneously

Job Responsibility

Develop and author IOQ protocols for computerized systems, ensuring alignment with user requirements and regulatory standards
Execute IOQ protocols in a cleanroom environment, coordinating with cross-functional teams (Engineering, QA, Manufacturing)
Perform data collection, deviation management, and ensure timely resolution of discrepancies during qualification activities
Generate and finalize IOQ reports, ensuring complete documentation and compliance with internal SOPs and industry guidelines
Support the qualification of iFIX SCADA system and related MES components for manufacturing operations
Collaborate with IT and Automation teams to ensure system configurations meet validation requirements
Maintain validation documentation in compliance with FDA 21 CFR Part 11 and other applicable regulations
Participate in risk assessments and impact analyses for system changes

What we offer

Mentorship
Career growth opportunities
Comprehensive benefits

Fulltime

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FDA Validation Engineer

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