Validation Engineer
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Job Location:
Elmwood Park, IL - USA
Monthly Salary:
$ 90 - 120
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Basic Function:
This position resides in the Quality Department with dual responsibility for equipment software and process validation as well as supporting continuous improvement activities for contract manufactured orthopedic medical devices.
Responsibilities:
1. Serves as the primary Validation Engineer with responsibility for ensuring all equipment and manufacturing processes are qualified and validated to both internal procedures and external/industry standards
2. Establishes all aspects of a validation project including but not limited to authoring/reviewing/executing Validation Master Plans (VMP) and procedure Validation Plans (VP) User Requirements Specifications (URS). commissioning Installation Qualification (IQ) Operation Qualification (OQ) and Performance Qualification (PQ)protocol/reports risk assessments and periodic validation/qualification reviews
3. Develops the companys validation plan and strategy. execution and implementation. Creates and maintains a current validation schedule. Submits reports regarding scope and status of validation activity as needed
4. Analyzes information and draws conclusions based upon technical knowledge of the systems. Works with different groups/departments to ensure correct interpretation and execution of information and protocols
5. Coordinates validation activities between the team customers and suppliers
6. Works with facilities operations purchasing the development execution and change control of validation protocols
7. Maintain up to date knowledge of validation requirements practices and procedures. Coaches other members of the team participating in validation activities
8. Supports continuous improvement and lean initiatives to identify and drive out waste from current manufacturing processes while maintaining the highest level of quality
9. Works independently and/or within a team on special/non-recurring ongoing projects
10. Performs other duties as assigned
Salary range: $90k - $120k
Education:
BS in mechanical engineering or equivalent Masters degree a plus
Experience:
1. Minimum of 3 years experience working in a similar position as well as writing and executing validation documents IQ/OQ/PQ protocols
2. Experience working in a highly regulated manufacturing industry is a must. Prior exposure to Medical Device industry/working in compliance to ISO 13485 is a plus
3. Experience with both conventional CNC and robotic manufacturing processes
4. Good understanding of measurement system analysis including Gage R&R
5. Ability to use statistical techniques using MiniTab
6. Familiar with Good Manufacturing Practices (GMP) as well as Lean Manufacturing/Six Sigma. Formal Six Sigma training Green or Black belt certification a plus
7. Excellent communication and interpersonal skills.- must be mobile ability to clearly communicate with customers and plant personnel at all levels is a must
8. Capable of composing technical detailed written reports and other communications are required
9. Excellent organization skills with the ability to handle multiple priorities and deadlines
10. Proven record of success working in a fast-paced high pressure deadline-driven work environment
11. Proficiency with various software programs including MS Office Suite (Word Excel PowerPoint)
Physical demands:
1. Required to stand for long periods of time
2. May involve some repetitive motions
3. Must be able to lift up to 25 lbs.
4. May also engage in frequent bending stooping squatting pushing and pulling
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Synerfac Staffing Employment Agencies are located across the U.S. for your convenience. Synerfac specializes in accounting, administrative, engineering, IT skilled trades, scientific, sales staffing and more.
