Top 292 Validation engineer Jobs in Somerset Nj

Validation Engineer
Empower Lifescience —Springfield, NJ
- $40 - $65 an hour
- Contract
- Mid-level
- Continuous improvement
- In-person
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Engineer/Scientist-Technical Operations Validation
Celltrion Branchburg, LLC —Branchburg, NJ
- $72,000 - $116,000 a year
- Full-time
- Microsoft Outlook
- Engineering
- Mid-level
- Paid holidays
- Disability insurance
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6d
Senior Mechanical Engineer - Piezo
Hoerbiger —Shrewsbury, NJ
- $110,000 - $170,000 a year
- Full-time
- 5 years
- Office
- Master's degree
- Health savings account
- Paid holidays
6d
Senior Quality Engineer
NJM Insurance —Ewing, NJ
- $100,402 - $116,574 a year
- Full-time
- Hybrid work
- Computer science
- 7 years
- Computer Science
- Paid parental leave
- Disability insurance
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Sr Packaging and Product Device Engineer
Zing Recruiting —Somerset, NJ
- $145,000 a year
- 5 years
- Senior level
- Leadership
- Health insurance
- Dental insurance
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Senior Azure Infrastructure Automation Engineer
Experis —Warren, NJ
- Contract
- Senior level
- Leadership
- Communication skills
- Health savings account
- Disability insurance
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4d
Design and Electromechanical Engineer
Emerson —Florham Park, NJ
- $100,000 - $130,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Assembly
- Paid parental leave
- Health insurance
Grid Modernization Engineer ADMS
Leidos —South Plainfield, NJ
- $107,900 - $195,050 a year
- Full-time
- Hybrid work
- Computer science
- Computer Science
- Engineering
Quality Engineer
Interact Engineering LLC —Whippany, NJ
- $50 an hour
- Temporary
- 5 years
- Mid-level
- Master's degree
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12d
Quality Assurance Director
Jem Accessories —Woodbridge, NJ
- From $90,000 a year
- Full-time
- Master's degree
- Analysis skills
- Mentoring
- Health insurance
- Dental insurance
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Optomechanical Engineer
Logiqal —Princeton, NJ
- $125,000 - $200,000 a year
- Full-time
- Leadership
- Mechanical knowledge
- Entry level
- Health insurance
- Dental insurance
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Validation Engineer
Zenith LifeScience —South Plainfield, NJ
- $70,000 - $80,000 a year
- Full-time
- 3 years
- Bachelor's degree
- Product management
Lead Validation Engineer
Zenith LifeScience —South Plainfield, NJ
- $136,000 a year
- Full-time
- 3 years
- Master's degree
- Databases
Computer System Validation (CSV) Engineer
Kashiv BioSciences, LLC —Piscataway, NJ
- $65 - $75 an hour
- Extended hours
- 5 years
- Bachelor's degree
- Travel
Validation Engineer II
AbbVie —Branchburg, NJ
- $75,000 - $142,500 a year
- Full-time
- Computer science
- Computer Science
- Engineering
- Paid holidays
- Health insurance
Mechanical Design Engineer
OrganOx —Madison, NJ
- $85,000 - $95,000 a year
- Full-time
- Hybrid work
- Mid-level
- Analysis skills
- 2 years
- Paid holidays
- Disability insurance
Quick Apply
Computer System Validation Engineer
Katalyst Healthcares & Life Sciences —Princeton, NJ
- Contract
- Computer Science
- Mid-level
- Bachelor's degree
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7d
Mechanical Engineer | Bentley Labs
THG —Edison, NJ
- $95,000 - $110,000 a year
- Bilingual
- Mid-level
- Ability to lift 50 pounds
Quick Apply
Test Engineer
AyNuX —Newark, NJ
- Mid-level
- Windows
- Scripting
Validation Engineer
AM Logic Corporation —Edison, NJ
- Email
- Mid-level
- Bachelor's degree

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validation engineer jobs near somerset nj

Validation Engineer

Empower Lifescience
Springfield, NJ

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Job Details

Contract
$40 - $65 an hour

Qualifications

Quality control corrective actions
Content creation for technical audiences
Pharmaceutical regulatory compliance
Interpreting technical drawings
Mechanical system commissioning projects
Technical writing experience within manufacturing
Production deviation management
Equipment troubleshooting
Corrective and preventive actions (CAPA)
FDA 21 CFR Part 11
GMP
Manufacturing facility experience
Records management
Production validation processes
Continuous improvement
Pharmaceutical company experience
Collaboration with manufacturing teams
Biomedical regulatory compliance
Industrial equipment
Technical troubleshooting support
Commissioning phase involvement
Root cause analysis
Field commissioning
Project stakeholder communication
Cross-functional communication

Full Job Description

Role Description The Validation CQV Engineer role is a contract, on-site position based in Springfield, NJ. In this role, the engineer will plan, execute, and document commissioning, qualification, and validation (CQV) activities for equipment, utilities, and processes within GMP-regulated environments. Daily responsibilities include developing and reviewing validation protocols and reports, performing system walkthroughs and testing, and ensuring alignment with regulatory and internal quality standards. The engineer will collaborate with cross-functional teams such as engineering, quality assurance, and operations to troubleshoot issues, support root cause investigations, and implement corrective and preventive actions. Additional tasks may involve maintaining validation documentation, supporting audits and inspections, and contributing to continuous improvement of validation practices and lifecycle management.

We are seeking an experienced Validation CQV Engineer to support commissioning, qualification, validation, and project activities within a pharmaceutical manufacturing environment. The successful candidate will work closely with Engineering, Manufacturing, Quality Assurance, Automation, Facilities, and external vendors to ensure equipment, systems, utilities, and processes are properly commissioned, qualified, and validated in compliance with applicable regulatory requirements and company procedures.

This position is ideal for a detail-oriented professional with strong knowledge of pharmaceutical validation practices, GMP requirements, and CQV documentation.

Key Responsibilities

Develop and execute Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical manufacturing facilities, equipment, utilities, and systems.
Prepare, review, and execute validation documentation, including:
User Requirements Specifications (URS)
Functional/Design Specifications
Risk Assessments
Commissioning Test Plans
FAT/SAT protocols
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Process and Cleaning Validation documentation
Validation Summary Reports
Support equipment and system commissioning activities from installation through qualification and turnover.
Develop and execute test scripts and qualification protocols in accordance with approved procedures.
Review engineering documentation, drawings, specifications, manuals, and vendor documentation.
Coordinate with Engineering and vendors to resolve equipment and system deficiencies.
Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
Support deviation, discrepancy, investigation, and CAPA activities associated with CQV execution.
Ensure validation activities are performed in accordance with cGMP, FDA, GxP, and applicable regulatory requirements.
Review and approve validation documentation, as applicable.
Participate in project meetings and provide CQV status updates, schedules, risks, and deliverables.
Support change control activities related to validated systems and equipment.
Work with Quality Assurance to ensure validation activities are completed in compliance with approved procedures.
Assist with validation lifecycle management and periodic review activities.
Support commissioning and qualification of systems such as:
Temperature Mapping Equipment
Incubators
Refrigerators/ Freezers
Cell cleaning and processing equipment
Centrifuges
Scales/ Balances
Cell Counters
Cryopods
Controlled Rate Freezers
Bio Safety Cabinets
LN2 Freezers
Cleanrooms
Processing/ Manufacturing equipment
Compressed gases

Qualifications

Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, or a related technical field.
2 or more years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
Experience with Commissioning, Qualification & Validation (CQV) activities.
Strong understanding of GMP/GxP requirements and FDA-regulated environments.
Experience writing, executing, and reviewing validation protocols and reports.
Experience with IQ/OQ/PQ and equipment/system qualification.
Experience with FAT/SAT, commissioning, and equipment turnover.
Strong technical writing and documentation skills.
Ability to interpret engineering drawings, P&IDs, equipment specifications, and technical documentation.
Strong problem-solving and troubleshooting skills.
Ability to work independently while collaborating effectively with cross-functional teams.
Excellent organizational and project-management skills.
Strong attention to detail and ability to manage multiple priorities.

Required Experience

Pharmaceutical or biopharmaceutical manufacturing experience.
Hands-on experience with CQV/Validation execution.
Experience working under cGMP/GxP requirements.
Experience with validation documentation and electronic document management systems.
Experience supporting deviations, change controls, investigations, and CAPAs.
Experience working with Engineering, QA, Manufacturing, Automation, Facilities, and external contractors/vendors.

Preferred Qualifications

Experience with new facility construction, facility expansion, or major capital projects.
Knowledge of FDA, EMA, EU GMP, and ISPE guidelines.
Experience with 21 CFR Part 11 and computerized system validation (CSV).
Experience with clean utilities and process utilities.
Experience with process, cleaning, and equipment validation.
Familiarity with Quality Risk Management (QRM) principles.
Experience with Veeva, ValGenesis, Maximo or similar systems.

Technical Skills

Candidates should have knowledge of:

Commissioning & Qualification
Equipment Qualification
Facility Qualification
Utility Qualification
IQ/OQ/PQ
FAT/SAT
Process Validation
Cleaning Validation
Computerized System Validation
GMP/GxP
FDA regulations
21 CFR Part 11
Risk Assessments
Change Control
Deviations & CAPA
Data Integrity / ALCOA+

Pay: $40.00 - $65.00 per hour

Work Location: In person

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Refine Your Search

validation engineer jobs in somerset nj

Validation Engineer

Engineer/Scientist-Technical Operations Validation

Senior Mechanical Engineer - Piezo

Senior Quality Engineer

Sr Packaging and Product Device Engineer

Senior Azure Infrastructure Automation Engineer

Design and Electromechanical Engineer

Grid Modernization Engineer ADMS

Quality Engineer

Quality Assurance Director

Optomechanical Engineer

Validation Engineer

Lead Validation Engineer

Computer System Validation (CSV) Engineer

Validation Engineer II

Mechanical Design Engineer

Computer System Validation Engineer

Mechanical Engineer | Bentley Labs

Test Engineer

Validation Engineer

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