Top 26 Quality engineer Jobs in Bethlehem Pa

Validation Engineer
Particle Sciences Inc, an Agno Pharma Company —Bethlehem, PA
- Full-time
- Background check
- Engineering
- Mid-level
- Health savings account
- Health insurance
Quick Apply
3d
Software Quality Assurance Engineer
Edovate Learning Corporation —Catasauqua, PA
- $23 - $28 an hour
- Part-time
- Remote
- Mid-level
- Analysis skills
- Bachelor's degree
Quick Apply
Quality Engineer I - Manufacturing
B. Braun US Device Manufacturing LLC —Allentown, PA
- $85,300 - $95,300 a year
- Mid-level
- Bachelor's degree
- Product management
- Health insurance
- 401(k)
Quality Engineer
Coherent Corp. —Easton, PA
- $123,178 - $125,000 a year
- Email
- 7 years
- Writing skills
- Assembly
Engineer - Supplier Quality (Food Safety and Quality Assurance)
Freshpet —Bethlehem, PA
- $95,000 - $110,000 a year
- Full-time
- Databases
- Travel
- US work authorization
- Paid parental leave
- Disability insurance
7d
Principal Engineer Quality
Olympus —Center Valley, PA
- $106,402 - $148,963 a year
- Full-time
- Remote
- Engineering
- Analysis skills
- Senior level
- Paid parental leave
- Paid holidays
Principal Quality Engineer
Olympus —Center Valley, PA
- $106,402 - $148,963 a year
- Full-time
- Remote
- Bachelor of Science
- 3 years
- Travel
- Paid parental leave
- Paid holidays
Quality Assurance Engineer, Process Control
Sharp Clinical Services —Allentown, PA
- Full-time
- Microsoft Excel
- Mid-level
- Math
Senior Engineer, Quality System
Olympus —Center Valley, PA
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- 5 years
- Paid parental leave
- Paid holidays
Verification & Validation Engineer I
Dexis —Quakertown, PA
- $55,500 - $94,500 a year
- Writing skills
- Mid-level
- Windows
- Paid holidays
- Disability insurance
Contract QA Engineer - AI Trainer
DataAnnotation —Delaware, NJ
- $50 - $100 an hour
- Part-time
- Remote
- Writing skills
- English
- Mid-level
- Flexible schedule
Quick Apply
Validation Engineer
CAI —Allentown, PA
- $72,800 - $80,100 a year
- Full-time
- Customer service
- Mid-level
- Team management
- Disability insurance
- Health insurance
Quick Apply
Quality Manager
OPW —Allentown, PA
- Overtime
- Customer service
- Engineering
- Senior level
- Paid jury duty
- Commuter assistance
3d
Quality Inspector I
MW Components —Easton, PA
- Basic math
- High school diploma or GED
- Ability to lift 50 pounds
Quick Apply
2d
Continuous Improvement-Industrial Engineer
Safran —Bethlehem, PA
- Full-time
- Bachelor's degree
- Senior level
Quality Engineer
Oliver Healthcare Packaging —Doylestown, PA
- Weekends as needed
- 6 years
- Engineering
- Microsoft Office
Quick Apply
Product Quality Assurance Supervisor
Victaulic —Easton, PA
- Full-time
- 7 years
- Engineering
- Analysis skills
2nd Shift Quality Inspector - Forks Township, PA
Victaulic —Easton, PA
- Overtime
- Mid-level
- High school diploma or GED
- Communication skills
- Wellness program
- Disability insurance
Director, Design Assurance (Japan based)
Olympus —Center Valley, PA
- $154,866 - $216,812 a year
- Full-time
- Remote
- Bachelor of Science
- HIPAA
- Product management
- Paid parental leave
- Paid holidays
Continuous Improvement Engineer
Penn Color —Hatfield, PA
- Full-time
- 5 years
- Research
- Analysis skills
- Health insurance
- Paid time off

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quality engineer jobs near bethlehem pa

Validation Engineer

Particle Sciences Inc, an Agno Pharma Company
Bethlehem, PA

Quick Apply

Job Details

Full-time
3 days ago

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance
401(k) matching
Life insurance

Qualifications

Interpreting technical drawings
Electrical schematic reading and interpretation
Piping and instrumentation diagrams (P&IDs)
Production validation processes
Electrical layout diagram interpretation

Full Job Description

Position Summary

The Validation Engineer is responsible for planning, executing, documenting, and maintaining qualification and validation activities supporting GMP manufacturing operations. This role ensures facilities, utilities, equipment, computerized systems, cleaning processes, sterilization processes, and manufacturing processes are qualified and maintained in compliance with CGMP requirements while supporting clinical and commercial pharmaceutical manufacturing.

Essential Responsibilities

Develop, execute, review, and maintain qualification and validation protocols and reports, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Performance Qualification (PPQ), Cleaning Validation, Sterilization Validation, and Validation Summary Reports (VSR).
Support the development and execution of Computer System Validation (CSV).
Lead qualification and validation activities for facilities, cleanrooms, utilities, manufacturing equipment, laboratory equipment, analytical instruments, and computerized systems.
Develop and review User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specifications (DS), traceability matrices, and validation plans.
Review vendor documentation including drawings, P&IDs, manuals, FAT/SAT documentation, and technical specifications.
Plan, coordinate, and execute Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
Evaluate equipment, systems, facilities, and process changes for validation impact and provide technical support for change controls.
Author and review SOPs, validation procedures, protocols, technical reports, and supporting GMP documentation.
Support technology transfer, equipment implementation, facility expansion, and new product introductions through qualification and validation activities.
Troubleshoot validation deviations, investigations, and CAPAs while identifying root causes and implementing effective corrective actions.
Perform validation risk assessments using Quality Risk Management (QRM) principles.
Ensure validation activities remain compliant with applicable regulatory requirements, company procedures, and industry standards.
Support internal audits, client audits, and regulatory inspections related to validation.
Mentor junior validation personnel and provide technical guidance as required.
Participate in continuous improvement initiatives to improve validation lifecycle management and operational efficiency.

Qualifications

Bachelor's degree in Engineering, Pharmaceutical Sciences, Biology, Chemistry, Biotechnology, or another related scientific discipline.
Minimum of four (4) years of validation experience within a GMP-regulated pharmaceutical, biotechnology, medical device, or CDMO environment.
Experience supporting sterile pharmaceutical manufacturing operations is preferred.
Working knowledge of equipment qualification, facility qualification, utility qualification, process validation, cleaning validation, sterilization validation, and computerized system validation.
Working knowledge of applicable CGMP regulations, GxP principles, and industry standards including FDA, EU GMP (Annex 1 where applicable), ICH, ISPE, ASTM, GAMP 5, and applicable USP guidance.
Experience supporting technology transfers, facility expansions, commissioning, and qualification activities is preferred.
Experience supporting FDA, international regulatory authority, and client inspections is preferred.
Experience supporting cleaning and sterilization validations including CIP, SIP, autoclave, VHP, etc.
Ability to interpret engineering drawings, P&IDs, electrical schematics, specifications, and technical documentation.
Strong technical writing, project management, communication, analytical, and problem-solving skills.
Professional certifications related to validation, engineering, automation, or quality are desirable.

Equal Opportunity Employer

Job Type: Full-time

Benefits:

401(k)
401(k) matching
Dental insurance
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

quality engineer jobs in bethlehem pa

Validation Engineer

Software Quality Assurance Engineer

Quality Engineer I - Manufacturing

Quality Engineer

Engineer - Supplier Quality (Food Safety and Quality Assurance)

Principal Engineer Quality

Principal Quality Engineer

Quality Assurance Engineer, Process Control

Senior Engineer, Quality System

Verification & Validation Engineer I

Contract QA Engineer - AI Trainer

Validation Engineer

Quality Manager

Quality Inspector I

Continuous Improvement-Industrial Engineer

Quality Engineer

Product Quality Assurance Supervisor

2nd Shift Quality Inspector - Forks Township, PA

Director, Design Assurance (Japan based)

Continuous Improvement Engineer

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