Position: Validation Engineer
Location: Raynham MA *From Day 1 Onsite
| | Validation Engineer-in Medical Device Validation Engineer - Preferable from Medical device background
Key Responsibilities:
Writing and execution of validation protocols and reports (Le IQ OQ PQ etc.)
Developing and implementing manufacturing processes preparatiori of specifications and operator instructions process studies production readiness investigations root cause
Updating procedures manufacturing specifications bills routes and travelers for product & process changes in the PLM system.
Working with OEM equipment manufacturers and distributors to develop user requirements.
Work on new asset commissioning
Working with multi functional teams (Operations Value Stream OpEx Planning Engineering and Quality) to align on validation strate to align on validation strategy author validation documents coordinate execution and discomment approvals
Maintains positive and cooperative communication and collaboration with all levels of employees customers contractors and vendors.
Ensuring compliance with US. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operating procedures processes and task assignments when supporting projects
Qualifications
Education:
Bachelor of Science Degree from accredited institution in Manufacturing Engineering Mechanical Engineering Industrial Engineering or a related degree.
Experience and Skills:
Required:
2-4 years of experience in manufacturing and/or process engineering
Strong technical writing skills with appropriate awareness of intended audience.
Ability to effectively communicates across multiple audiences including operators peers and management in both written and onal manners
Process validation experience
Experience in a Medical Device arid/or regulated manufacturing work environment
Persuasive communication and interpersonal skills
Digital literacy including use of Microsoft Office tools.
Preferred:
Experience working in a regulated industry such as Medical Device.
Experience with machining processes metal finishing processes laser processing or production automation. Hands-on experience with machining processes casting metal finishing processes laser processing or production automation.
Knowledge of statistical data analysis and associated tools (eg. Minitab). Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T).
Willingness to support global projects which may include travel. |
Position: Validation Engineer Location: Raynham MA *From Day 1 Onsite Validation Engineer-in Medical Device Validation Engineer - Preferable from Medical device background Key Responsibilities: Writing and execution of validation protocols and reports (Le IQ OQ PQ etc.) Developing...
Position: Validation Engineer
Location: Raynham MA *From Day 1 Onsite
| | Validation Engineer-in Medical Device Validation Engineer - Preferable from Medical device background
Key Responsibilities:
Writing and execution of validation protocols and reports (Le IQ OQ PQ etc.)
Developing and implementing manufacturing processes preparatiori of specifications and operator instructions process studies production readiness investigations root cause
Updating procedures manufacturing specifications bills routes and travelers for product & process changes in the PLM system.
Working with OEM equipment manufacturers and distributors to develop user requirements.
Work on new asset commissioning
Working with multi functional teams (Operations Value Stream OpEx Planning Engineering and Quality) to align on validation strate to align on validation strategy author validation documents coordinate execution and discomment approvals
Maintains positive and cooperative communication and collaboration with all levels of employees customers contractors and vendors.
Ensuring compliance with US. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operating procedures processes and task assignments when supporting projects
Qualifications
Education:
Bachelor of Science Degree from accredited institution in Manufacturing Engineering Mechanical Engineering Industrial Engineering or a related degree.
Experience and Skills:
Required:
2-4 years of experience in manufacturing and/or process engineering
Strong technical writing skills with appropriate awareness of intended audience.
Ability to effectively communicates across multiple audiences including operators peers and management in both written and onal manners
Process validation experience
Experience in a Medical Device arid/or regulated manufacturing work environment
Persuasive communication and interpersonal skills
Digital literacy including use of Microsoft Office tools.
Preferred:
Experience working in a regulated industry such as Medical Device.
Experience with machining processes metal finishing processes laser processing or production automation. Hands-on experience with machining processes casting metal finishing processes laser processing or production automation.
Knowledge of statistical data analysis and associated tools (eg. Minitab). Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T).
Willingness to support global projects which may include travel. |
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Job Location:
Monthly Salary:
Not Disclosed
Posted on:
22 hours ago
Vacancies:
1 Vacancy
