Validation Engineer III - Katalyst Healthcares and Lifesciences - Plainsboro, NJ, US | Dice.com

Katalyst Healthcares and Lifesciences

Apply Now

Validation Engineer III

Plainsboro, NJ, US • Posted 10 days ago • Updated 8 hours ago

Full Time

On-site

Apply Now

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Fitment

Dice Job Match Score™

🔗 Matching skills to job...

Job Details

Skills

Problem Solving
Organized
Process Flow
Change Control
Research
Risk Management
Management
Supervision
Routing
Risk Assessment
Data Integrity
Test Methods
Product QA
Scheduling
Collaboration
Good Manufacturing Practice
Design Controls
ISO 9000
Reporting
Biomedicine
Mechanical Engineering
Electrical Engineering
Science
Biology
Chemistry
Quality Assurance
Pharmaceutics
Communication
Medical Devices
Manufacturing
FOCUS
Conflict Resolution
Technical Writing
Documentation
Mapping

Summary

Job Description:

Software qualification experience (specifically for calibration software); equipment/process qualification experience with a preference for experience with temperature mapping (KAYE validator probes).
Qualified candidates must be experienced in one or more of the following areas of validation:
Equipment Qualification.
Process Qualification.

Responsibilities:

Responsibilities associated with this position are directly associated with the introduction and launching of new equipment or products and processes into a manufacturing facility. The candidate must utilize problem solving techniques to resolve issues and conflicts to meet the high level goals set forth by the organization. The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint. The candidate must be familiar with process flow of a medical device organization, including the regulatory impact of change and the documentation path of a compliant process. The candidate must possess technical writing experience in protocol generation and procedure generation. Some experience is required in master plan generation and the change control life cycle. The candidate must be a team player who thrives in a team environment but also has the capability to work on their own to research and investigate. Gown qualification is a plus, with an understanding of clean room practice and cGMP environments. The qualified candidate must understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting.

Supervision Received
Under direct supervision of Manager, Quality Engineering.
Supervision Exercised:
No supervisory duties are required.
To perform this job successfully, an individual must be able to perform each essential duty
Satisfactorily:
Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
Generation and execution of software qualification documentation including risk assessment, data integrity checks, trace matrices.
Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
Complete test method validation, gauge r&r studies and other qualifications or studies to support product testing.
Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments.
Develop statistically based sampling plans for in-process and final test sequencing.
Ensure that all projects are following cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
Support and address comments and suggestions associated with validation and engineering documentation.
Protocol, Deviation, and summary report generation and approval.

Requirements:

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Bachelor's degree in engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
4 to 7 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.
Demonstrates excellent organizational and communication skills.
Experience with qualifying medical device manufacturing equipment.
Results oriented with a strong focus on quality principles and conflict resolution.
Excellent technical writing skills with a thorough understanding of good documentation practies.
Experience using temperature mapping equipment including Kaye Validators and Val probes.

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: f608f1358401da3a78a1df18e73e54c5
Posted 10 days ago

Create job alert

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

Similar Jobs

Process/Validation Engineer

Branchburg, New Jersey

•

Today

Responsibilities: Process and Cleaning Validation Experience. Equipment Qualification (IOQ/PQ). Quality System Experience (Veeva, Track wise, Compliance Wire). Medical Device or Pharmaceutical Experience Required. Preferred Medical Device with 3-5 Years. Statistical Analysis (Minitab or JUMP). The Process/Validation Engineer is responsible for providing engineering production support including: Implementing process and technology improvements. Process and Cleaning Validation. Equipment Qualifica

Full-time

Validation Engineer

New Brunswick, New Jersey

•

Today

Job Description: Computerized Systems Validation (CSV) position involves ensuring that GxP-regulated computer systems and software comply with current Good Manufacturing Practices (cGMP) regulations, international guidelines (like 21 CFR Part 11 and Annex 11), and company standards by validating their functionality throughout their lifecycle. Key responsibilities include developing and reviewing validation documentation (protocols, reports), performing risk and impact assessments, coordinating

Full-time

Validation Engineer

Raritan, New Jersey

•

Today

Job Description: We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems, combined with technical writing/documentation skills. This role is critical in ensuring compliance, validation, and accurate documentation of enterprise applications, particularly in regulated environments (GxP/21 CFR Part 11). Responsibilities: Perform Computer System Validation (CSV) activities for SAP and OpenText systems. Develop and execute validation protocols (IQ, OQ,

Full-time

Mid/Senior Level Validation Specialist/Engineer

Pennsylvania

•

Today

Roles & Responsibilities: Minimum of Four (4) years of experience with commissioning and qualification including using ISPE C&Q guidelines. Knowledge of Kneat e-validation software preferred. Prior experience with analytical instrumentation qualification and controlled temperature unit qualification is required. Strong technical writing skills, verbal and written communication skills. Strong interpersonal skills (requires interaction with client employees). Responsible for the development and ex

Full-time