Hiring for Validation Engineer with Medical Devices, Blue Ash, OH - Onsite
Shiv Singh
Role: Validation Engineer with Medical Devices
Location: Blue Ash, OH- Onsite
Exp: 5-7 Year
**CPT/OPT can apply**
Rate:$40-45
JD:--- Role Descriptions: "Experience Range:
Ohio, Cincinnati, 45242 · 3–6 years of relevant experience in packaging engineering, validation, or quality engineering · Minimum 2–3 years hands-on experience in packaging testing and documentation · Experience working in a regulated industry (medical devices, pharma) preferred · Exposure to cross-functional projects and change management processes · Prior involvement in test protocol development and execution is essential · Familiarity with document control systems and compliance requirements expected · Experience with labeling review and regulatory documentation is an advantage
Must Have Technical/Functional Skills
· Strong knowledge of packaging materials, design principles, and engineering drawings
· Proficiency in packaging testing standards (ISTA, ASTM, ISO) and validation methods
· Experience in developing and executing test protocols and validation activities
· Expertise in technical documentation, including test reports and controlled documents
· Familiarity with document control systems and change management processes (ECR/ECO)
· Understanding of regulatory requirements and labeling compliance standards
· Ability to analyze test data and perform root cause analysis · Proficiency in tools like MS Excel, Minitab, CAD, and PLM/ERP systems · Strong cross-functional collaboration and stakeholder communication skills · Effective project management, problem-solving, and attention to detail
Roles & Responsibilities
· Review and update packaging drawings to reflect project changes
· Collaborate with the team to track current packaging status
· Assess and identify testing requirements arising from project changes
· Develop test protocols and conduct validation testing
· Prepare test reports and ensure routing through the document control system for approval
· Maintain and update packaging-related documentation
· Review labelling and WE0060 forms for compliance
· Prepare and present status reports along with key assumptions
Generic Managerial Skills, If any
· Meet delivery promise in terms of budget and timescales.
· Track Project progress and make necessary changes to project execution as needed to ensure achievement of projec
goals.
· Work within a multi-discipline team, consisting of the R&D Development Group, Marketing, Quality, Operations
· Liaison with customer designated point of contact and functional area point of contact.
· Multiple Project Planning and execution
· Take complete ownership of the quality aspects of the project including managing other quality associates working i
the project.
· Knows whether to outsource based on capacity, criticality, and complexity of the activity.
· Take a well thought out and planned approach involving multiple arguments or steps. Anticipates the interests,
reactions, or objections of others and adapts a multi-part influence strategy
Essential Skills: Ethicon Project Support
Desirable Skills:
Keyword:
Skills: EIS : Medical Device & Regulations~EIS : New Product Development (NPD) Methodology and Management
Thanks and Regards,
Shiv Singh
Technical Recruiter
Siri InfoSolutions Inc, 3 Ethel Rd, Suite # 301, Edison NJ 08817
Hangouts – shiv.s...@gmail.com
Mail Id: shiv....@siriinfoinc.com
LinkedIN –https://www.linkedin.com/in/shiv-singh-835621117/
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