Top 154 Lims validation engineer Jobs

CCI Technology Lead
DDL, Inc. —Eden Prairie, MN
- $120,000 - $140,000 a year
- Full-time
- 7 years
- Engineering
- Analysis skills
- Commuter assistance
- Health savings account
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9d
Chemical Engineer - Direct Liquid Cooling
Performance Fluid Experts Group —Cincinnati, OH
- Full-time
- Background check
- Mid-level
- 3 years
- Paid holidays
- Health insurance
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1d
Chemical Engineer - Direct Liquid Cooling
Performance Fluid Experts Group —Danbury, CT
- Full-time
- Background check
- Mid-level
- 3 years
- Paid holidays
- Health insurance
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1d
Validation Engineer
Celltrion Branchburg, LLC —Branchburg, NJ
- $72,000 - $116,000 a year
- Full-time
- Microsoft Outlook
- Computer Science
- Engineering
- Paid holidays
- Disability insurance
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Computer System Validation Engineer
Katalyst Healthcares & Life Sciences —New Wilmington, PA
- Contract
- 8 years
- Senior level
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Software Validation Engineer
Trelleborg Sealing Solutions US Inc —Plymouth, MN
- $90,000 - $100,000 a year
- Monday to Friday
- Hybrid work
- Computer science
- Computer Science
- Engineering
- Disability insurance
- Health insurance
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Senior Software Engineer, LIMS (Hybrid)
NeoGenomics Laboratories —Ramsey, NJ
- Hybrid work
- Computer science
- 7 years
- Azure
- Employee stock purchase plan
- Paid holidays
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CSV Validation QC Engineer
supremesoft —Jersey City, NJ
- 7 years
- Quality control
- Senior level
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6420 - Senior CSV Engineer / Senior Validation Engineer
Verista, Inc. —King of Prussia, PA
- $70,491 - $118,062 a year
- Remote
- Senior level
- SDLC
- Commuter assistance
- Paid parental leave
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Labvantage LIMS Support Engineer
Capgemini —Cincinnati, OH
- $73,150 - $174,000 a year
- Full-time
- Mid-level
- SQL
- Bachelor's degree
- Paid holidays
- Disability insurance
Sr. Validation Engineer II
Takeda Pharmaceutical —Thousand Oaks, CA
- $116,000 - $182,270 a year
- Weekends as needed
- Microsoft Excel
- Bachelor of Science
- Continuous improvement
- Paid holidays
- Disability insurance
Computer System Validation (CSV) Engineer
Kashiv BioSciences, LLC —Piscataway, NJ
- Extended hours
- 5 years
- Bachelor's degree
- Travel
Principal System Engineer LIMS
Moderna, Inc. —Norwood, MA
- $130,800 - $209,400 a year
- Full-time
- Remote
- System design
- Bachelor's degree
- Experience equivalent to degree accepted
- Paid time off
- Adoption assistance
Staff Software Engineer
CareDx, Inc. —Brisbane, CA
- $140,000 - $175,000 a year
- Full-time
- Remote
- Computer science
- Computer Science
- HIPAA
- Commuter assistance
- Employee stock purchase plan
System Analyst & Validation Engineer
Siemens Healthineers —Walpole, MA
- $79,800 - $109,725 a year
- Full-time
- Computer science
- Computer Science
- Analysis skills
- Disability insurance
- Health insurance
QC Systems Engineer IV (LabVantage LIMS)
Resilience US, LLC —West Chester, OH
- $90,000 - $153,750 a year
- Full-time
- 5 years
- SQL
- Analysis skills
- Paid holidays
- Disability insurance
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MES Engineer
Validation & Engineering Group —Morrisville, NC
- Full-time
- 7 years
- Computer Science
- Engineering
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Automation Engineer (I, II, III)
Cellares —South San Francisco, CA
- $90,000 - $210,000 a year
- Full-time
- Computer Science
- Engineering
- System design
- Health insurance
- Dental insurance
Lead Bioinformatics Engineer
Quest Diagnostics —Secaucus, NJ
- $155,000 - $175,000 a year
- Full-time
- Bachelor of Science
- System design
- 3 years
- Employee stock purchase plan
- Disability insurance
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Labvantage LIMS Support Engineer
Capgemini Sogeti —Cincinnati, OH
- $73,150 - $174,000 a year
- Full-time
- Mid-level
- SQL
- Bachelor's degree
- Paid holidays
- Disability insurance
10d

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CCI Technology Lead

DDL, Inc.
Eden Prairie, MN

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Job Details

Full-time
$120,000 - $140,000 a year
9 days ago

Benefits

Commuter assistance
Health savings account
AD&D insurance
Paid holidays
Disability insurance
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Vision insurance
Pet insurance

Qualifications

USP standards
Experience in a quality control laboratory environment
Technical engineering
Technical documentation
ISO standards
Technical writing experience within manufacturing
Laboratory information management systems
Leak detection equipment usage
Managing engineering teams
Client management
Leading team collaboration initiatives
Biomedical regulatory compliance
Productivity software
Test validation method
FDA regulations

Full Job Description

We are looking for a seasoned CCIT expert to build and elevate Container Closure Integrity Testing laboratory operations, someone who brings deep USP <1207> knowledge, hands‑on instrumentation experience, and the confidence to guide both clients and industry peers. In this role, you will shape CCIT strategy, stand up laboratory operations, and represent the field across working groups and technical forums, all while training, mentoring, and developing the technical staff who will deliver high‑quality, compliant analytical services. If you’re excited to drive CCIT innovation, influence industry practice, and build a high‑performing laboratory function, we want to hear from you.

WHO WE ARE:

DDL, Inc. is a third-party testing facility dedicated to helping medical device and pharmaceutical companies across the globe bring products to market. For over 30 years, DDL has provided extraordinary customer service and specialized testing expertise to the medical device, pharmaceutical, and consumer goods industries for our clients’ safety and efficacy testing. We help save lives by providing the highest standards for package, product and material, and Container Closure Integrity testing.

COMPENSATION

This position has a starting base salary range of $120,000–$140,000 and includes eligibility to earn an annual bonus of up to 10% of base salary.

HOW YOU WILL CONTRIBUTE (Overview & Key Responsibilities):

The CCIT Technical Lead is responsible for establishing, leading, and managing Container Closure Integrity Testing (CCIT) laboratory operations in a regulated environment. This role serves as the technical subject matter expert for USP <1207> and related regulatory requirements, while overseeing method development, validation, and routine testing activities. The position combines technical leadership, operational management, and client-facing responsibilities to support high-quality, compliant laboratory services.

Develop and implement CCI strategies aligned with USP <1207>, FDA guidance, and industry best practices
Lead and manage day-to-day CCI laboratory operations, including staffing, scheduling, and workflow optimization
Serve as technical SME for CCI methods (vacuum decay, HVLD, helium leak detection, headspace analysis, etc.)
Design and develop CCI methods including vacuum decay, high voltage leak detection (HVLD), helium leak detection, and headspace analysis - Define method parameters, detection limits, and acceptance criteria based on package configuration and risk assessment
Lead internal and external audits for CCI, including FDA and client inspections
Review, support and approve protocols, reports, deviations, and CAPA investigations
Drive continuous improvement initiatives related to quality, efficiency, and lab performance
Collaborate with Business Development to support client proposals, project scoping and technical discussions
Execute and document method development, feasibility studies, and protocol-driven testing
Lead and support method validation activities and method transfer projects
Interpret test results, perform statistical analysis, and provide technical conclusions
Author and review technical documentation including protocols, reports, SOPs, and validation summaries as it relates to CCI
Collaborate with QA and regulatory teams to ensure compliance with cGMP, ISO 17025, and USP <1207>
Identify opportunities and develop CCI studies for publication.
Build and maintain relationships with key technical leaders and customer stakeholders in CCI analysis.
Proactively develop knowledge of industry & technology as it applies to the area of CCI Analysis to effectively support organization in identifying and growing future analytical expertise
Work proactively with the Commercial team to understand the voice of customer and put together a plan to bring the necessary capability and technology into the DDL organization to support our business
Train, mentor, and develop technical staff including scientists, engineers, and technicians

WHAT YOU NEED TO SUCCEED (Minimum Qualifications):

Bachelor’s or Master’s degree in Engineering, Chemistry, Materials Science, or related field
7+ years of experience in pharmaceutical, medical device, or regulated laboratory environment
Direct experience with CCIT methods and USP <1207> required
Experience in CDMO or contract testing laboratory environment required
Knowledge and understanding of CCIT instrumentation operation and test execution
Demonstrated leadership experience managing technical teams
Other Skills Required (computer, language, etc.): Microsoft Office, LIMS, QMS System
Ability to travel up to 20%

WHAT WILL SET YOU APART (Competencies Required):

Strong knowledge of cGMP, FDA regulations, and quality systems
Experience leading validation programs and regulatory audits
Strong technical writing and documentation skills
Familiarity with deterministic leak detection technologies
ISO 17025 laboratory experience
Six Sigma or Lean certification
Client-facing or consulting experience
Experience participating in industry working groups

WHY JOIN US:

If you’re a team player who is looking for a sense of accomplishment, the opportunity to grow both personally and professionally, and a place to call home, then DDL is the place for you! At DDL, Inc., we strive to offer a competitive salary along with a comprehensive benefits package that helps you and your family maintain health and well-being -both physically and financially. Our comprehensive benefits package includes:

Medical Insurance
Dental Insurance
Vision Insurance
Health Savings Account (HSA)
Flexible Spending Account (FSA)Voluntary Accident, Critical Illness, and Hospital Indemnity Insurance
Basic Life and AD&D / Voluntary Life and AD&D
Short-Term Disability
Long-Term Disability
Pet Insurance
Commuter Transit Benefits
401(k) Retirement Plan w/Safe Harbor Employer Contribution
Paid Holidays
PTO

It is DDL’s policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.

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Refine Your Search

lims validation engineer jobs

CCI Technology Lead

Chemical Engineer - Direct Liquid Cooling

Chemical Engineer - Direct Liquid Cooling

Validation Engineer

Computer System Validation Engineer

Software Validation Engineer

Senior Software Engineer, LIMS (Hybrid)

CSV Validation QC Engineer

6420 - Senior CSV Engineer / Senior Validation Engineer

Labvantage LIMS Support Engineer

Sr. Validation Engineer II

Computer System Validation (CSV) Engineer

Principal System Engineer LIMS

Staff Software Engineer

System Analyst & Validation Engineer

QC Systems Engineer IV (LabVantage LIMS)

MES Engineer

Automation Engineer (I, II, III)

Lead Bioinformatics Engineer

Labvantage LIMS Support Engineer

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