Validation Engineer Job at DataQuad (Houston)

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Validation Engineer

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

United Kingdom , Stockport

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Scientific/Engineering Degree or equivalent qualification or the right experience within a validation role
Experience working with Hydrogen peroxide decontamination systems
In depth knowledge of a specific validation/engineering skill set i.e. temperature mapping, airflow and smoke visualization, Biological Indicator application and processing etc
Working knowledge of validation in a pharmaceutical/FMCG/medical devices environment preferably
Experience with Equipment/Process systems, Cleaning Validation, HVAC, QA, QC, or Cleanroom systems would be preferred
Logical and practical perspective
Proactive approach to problem-solving
Analytical thinking and innovative problem-solving abilities
Self-motivated and driven
Excellent teamwork skills

Job Responsibility

Ensure Site Validation Master Plan (SVMP) is strictly adhered to
Develop and implement validation documents and protocols for a variety of processes, equipment, facilities, and systems, with a particular emphasis on aseptic manufacturing
Work closely with the validation team and teams from various departments to assist with the implementation of new processes, products, and equipment at the site
Actively participate in the assessment, review, and approval of changes that may impact the validation status of our facilities, equipment, processes, and systems
Conduct thorough reviews of validation execution and equipment changes carried out by external contractors and internal project team members
Take ownership of project management and execution for Capital Expenditure and Process Improvement Projects within the EMEA Validation project portfolio
Work with Quality Assurance to react to adhoc validation requirements
Support validation activities across all UK Compounding sites

What we offer

Competitive total compensation package
Professional development opportunities
High importance placed on work life balance
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

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

We are looking for a skilled Validation Engineer to join our team in San Francis...

Location

United States , San Francisco

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

2+ years in quality engineering, QA, or compliance—ideally in software, SaaS, or SaMD
Experience in regulated industries (pharma, biotech, med‑device, specialty chemicals)
Knowledge of 21 CFR Part 11, GAMP 5, ISO 9001/13485
Hands‑on CSV or software validation experience (IQ/OQ/PQ)
Strong communication and documentation skills
Self‑starter comfortable building new processes
U.S. work authorization required
sponsorship is not available

Job Responsibility

Plan and execute software validation activities in alignment with company procedures and regulatory standards
Develop and maintain validation documentation, including plans, test protocols, reports, and risk assessments
Analyze system requirements, design specifications, and user stories to confirm testability and compliance
Conduct and review functional, integration, regression, and user acceptance testing
Assess validation impacts during change control activities and update related documentation accordingly
Collaborate with engineering and product teams to identify risks and integrate quality measures during development
Prepare and provide documentation for audits and inspections, offering support as needed
Implement improvements to validation processes, templates, and tools for enhanced efficiency
Support customer or internal audits by contributing to validation-related responses and documentation
Design, implement, and maintain a QMS aligned with ISO 9001, ISO 13485, 21 CFR Part 11, and GAMP 5

What we offer

medical, vision, dental, and life and disability insurance
eligible to enroll in our company 401(k) plan

Validation Engineer

Seeking an experienced Validation Engineer to support qualification of manufactu...

Location

United Kingdom , London

Salary:

Not provided

Darwin Recruitment GmbH

Expiration Date

Until further notice

Requirements

Experience in equipment validation (pharma, med device, or similar)
Strong knowledge of validation lifecycle (IQ/OQ/PQ)
Familiarity with GMP/ISO standards
Good technical writing skills

Job Responsibility

Execute IQ/OQ/PQ for manufacturing equipment
Author and review validation documentation
Support commissioning and equipment qualification
Ensure GMP/ISO compliance
Assist with deviations, CAPA, and change control

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

Validation Engineer

The Validation Engineer will be guided by technical requirements to conduct syst...

Location

United States , Livermore

Salary:

100000.00 - 115000.00 USD / Year

ALTEN Technology USA

Expiration Date

Until further notice

Requirements

Bachelor or advanced degree in Engineering
1 to 5 years’ experience within the Engineering industry
Experience in automotive and/or heavy-duty vehicle testing/validation
Experience working with internal and external customers, engineering service suppliers, and supervising 3rd party test facilities
Knowledge of FMVSS, ADA, APTA Bus Procurement Guidelines, SAE HD vehicle standards, NFPA
Experience with “hands-on” troubleshooting, product assembly, prototyping, testing, and validation activities (on site and at remote locations)
Ability to build and maintain effective relationships with team members, customers, internal and external suppliers.
Familiarity with testing processes, including creating and executing test plans on vehicles supporting program timelines
Good verbal and written communication skills
Good organizational skills and attention to detail

Job Responsibility

Utilize program targets, system requirements and various control documents to develop and release comprehensive DV/PV plans, reports, recommendations
Create and execute test plans for associated vehicle systems and the entire vehicle. Report results, document non-conformances and collaborate with related design, systems and controls engineers to identify root cause of any failures, recommendations for improved specifications and opportunities for refinement.
Design and configure test methods, scripts and/or simulations to develop and validate system capabilities prior to vehicle integration.
Work closely with the Engineering teams to develop and deploy instrumentation and data acquisition strategies, data analysis methodologies and best practices for planning and conducting effective and timely testing activities.
Coordinate and document requirements, design verification and validation with component/subsystem/system suppliers or external testing resources/facilities to support overall program validation plan.
Gather and refine complex data sets into useable information and reports.
Support the maintenance and calibration of test equipment and instrumentation.
Support the development and deployment of engineering standards.
Support the development and management or requirements along with the associated design verification (DV) and production validation (PV) plans, including traceability between requirements, test results and test reports.

Fulltime

Validation Engineer

The Validation Engineer II is responsible for planning, executing, and closing I...

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, Life Sciences, or related field
3–5 years of validation experience in pharmaceutical or biotech manufacturing
Hands-on experience with system-level qualification of critical utilities and cleanroom environments
Strong understanding of GMP, FDA, and ICH guidelines
Proficiency in writing and executing IOQ protocols and reports
Ability to work in cleanroom environments and adhere to gowning procedures
Excellent documentation and communication skills
Strong analytical and problem-solving abilities

Job Responsibility

Develop and execute IOQ protocols for facility and utility systems such as Water for Injection (WFI), clean steam, nitrogen/compressed air gases, and cleanroom environments
Author detailed qualification protocols and ensure alignment with regulatory and company standards
Perform qualification activities in cleanroom environments, document results, and manage deviations and corrective actions
Compile and finalize qualification reports, ensuring traceability and compliance with GMP and validation standards
Work closely with engineering, operations, and quality teams to maintain validated state of systems
Ensure adherence to FDA, EMA, and ICH guidelines for system-level validation
Identify opportunities for improving qualification processes and system reliability

Validation Engineer

We’re hiring a Validation Engineer II to join our pharmaceutical manufacturing t...

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, Pharmaceutical Sciences, or related field
2–4 years in equipment validation within a pharmaceutical or regulated manufacturing environment
Familiarity with finished product manufacturing processes, including automated container handling, powder dosing, and liquid filling
Strong knowledge of cGMP and FDA guidelines
Proficiency in protocol writing, execution, and report generation
Ability to work in cleanroom environments and follow aseptic practices
Detail-oriented, organized, and excellent communication skills

Job Responsibility

Develop and execute IOQ protocols for manufacturing equipment and automated systems in compliance with cGMP and FDA guidelines
Perform qualification activities on: Automated container handling systems
Powder dosing equipment
Liquid filling machines
Document results, manage deviations, and compile final reports in accordance with SOPs and regulatory requirements
Collaborate with Engineering, Manufacturing, and Quality teams to support equipment qualification and troubleshooting
Provide technical input during equipment design and change control processes

Fulltime

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