Validation Engineer

Cambridge, MA, US • Posted 18 hours ago • Updated 5 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

🤯 Applying directly to the forehead...

Job Details

Skills

Medical Devices
IQ
OQ
PQ
Manufacturing
Test Methods
Computerized System Validation
GAMP
ISO 13485
FMEA
Change Control
Systems Analysis
ISO 9000
Analytical Skill
FOCUS
Technical Writing
Collaboration
Manufacturing Engineering
Research and Development
Quality Control
Regulatory Affairs

Summary

Roles & Responsibilities:

We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments.
Candidates must have strong hands-on expertise in IQ/OQ/PQ protocol development and execution for both new and legacy manufacturing processes and equipment, as well as Test Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP 5.
solid working knowledge of regulatory frameworks is essential - specifically ISO 13485, ISO 14971, EU IVDR 2017/746, and FDA 21 CFR 820 - along with demonstrated ability to develop and maintain Master Validation Plans, define CTQ-based acceptance criteria, and establish traceability across risk controls, process parameters, and validation outputs.
Experience with PFMEA and change control impact assessments is also expected.
On the analytical side, candidates should be proficient in statistical methods used in validation, including Measurement System Analysis (MSA), process capability analysis, and sampling plan design.
Familiarity with CLSI guidelines and ISO 15189 for analytical/diagnostic method validation is a plus given the IVD product focus.
Strong technical writing skills are a must - this person will be authoring protocols, deviation reports, and validation summaries that must hold up to regulatory scrutiny.
Cross-functional collaboration with Quality, Manufacturing Engineering, R&D, QC, Regulatory Affairs, and IT is a core part of the day-to-day, so candidates should be comfortable driving validation workstreams independently across multiple concurrent projects.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 8dbc991a2838f1f771edb1190861b084
Posted 18 hours ago

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Validation Engineer

Manchester, New Hampshire

•

Today

Roles & Responsibilities: We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments. Candidates must have strong hands-on expertise in IQ/OQ/PQ protocol development and execution for both new and legacy manufacturing processes and equipment, as well as Test Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP 5. solid working knowledge of regulatory frameworks is essential - specif

Full-time

Systems Design Quality Engineer

Cambridge, Massachusetts

•

Today

Job Title Systems Design Quality Engineer Job Description The Systems Design Quality Engineer supports the design control process, from validating design inputs to supporting verification, validation, and design transfer, ensuring compliance with regulatory and quality standards. Your role: Review and refine quality engineering documents, initiates quality improvement projects, and provides support in risk management.Resolve quality issues, utilizes post-market analytics for continuous improv

Full-time

USD 71,000.00 - 112,896.00 per year

Principal Engineer, Tech Ops (Drug Delivery Systems Testing & Verification)

Waltham, Massachusetts

•

Today

The Opportunity: Principal Engineer, Tech Ops (Drug Delivery Systems Testing & Verification) is an individual contributor role in the DDS department within CSL Technical Operations, which reports to the Director of Testing & Verification. The Principal Engineer, Tech Ops (Drug Delivery Systems Testing & Verification)plays an important role in the medical device and primary packaging development process to deliver specialized testing results from exploratory characterization to design verificatio

Full-time

Principal Engineer, Tech Ops (Drug Delivery Systems Testing & Verification)

Waltham, Massachusetts

•

Today

Full-time

Search all similar jobs