Validation Engineer
Validation Engineer
Posted on :
09-04-2025
Employer Active
1 Vacancy
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Job Description
Responsibilities:
- Develops and Executes Cleaning Validation Strategies: Creates plans protocols (IQ OQ PQ) and risk assessments to ensure effective cleaning processes for medical devices and equipment.
- Ensures Regulatory Compliance: Adheres to FDA 21 CFR 820 ISO 13485 and other relevant regulations participating in audits and maintaining uptodate knowledge.
- Analyzes Data and Reports Findings: Compiles and analyzes validation data writes comprehensive reports and identifies trends for process improvement.
- Collaborates CrossFunctionally: Works with Manufacturing Quality Assurance Engineering and other teams to implement cleaning strategies resolve issues and provide technical support.
- Manages and Improves Cleaning Processes: Leads continuous improvement initiatives manages change controls troubleshoots cleaning problems and ensures proper documentation and training. Creating maintaining and improving controlled technical documents such as prints procedures bills of materials and routers.
- Supporting a wide variety of processing applications such as machining finishing forging casting cleaning heat treating bonding molding etc.
- Conducting feasibility study to estimate a product cost and analyze capital equipment capacity and capability requirements.
- Establishing and improving process methods that meet performance and quality requirements.
- Developing and executing project plans and schedules for work activities.
- Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.
- Evaluating multiple options to select the most appropriate processes and machining methods.
- Execute equipment qualification or process validation project(s).
- Experience supporting medical device manufacturing.
- Cleaning & Upgrade Validations.
- Specific experience with process characterization equipment IQ/OQ process OQ and PQ.
- Specific experience with Test method Validation and Gage R&R.
- Experience with root cause analysis and problemsolving for both technical and process issues.
- Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISOAbility to lead and prioritize multiple mediumcomplexity project assignments and complete work in a timely manner.
- Good problemsolving skills using quality and statistical tools.
- BOM & Router creation and update.
- Ability to read and understand engineering drawings.
- Knowledge of basic quality tools risk analysis (PFMEA) statistics (SPC) Criticalto Quality (CTQ) Analysis.
- Knowledge of Quality System requirements ISO and FDA requirements.
- Ability to effectively work within a crossfunctional team to complete critical project tasks.
- Demonstrates good written and verbal communication skills.
- Experienced with control procedures such as the Change Management System Nonconformance Reports Engineering Specifications Corrective and Preventive Action (CAPA) and Work Instructions & Proficient with Statistical Process Control concepts process development CNC programming terminology and tooling design concepts.
- Microsoft Office Suite and Project.
Employment Type
Full Time
Key Skills
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