What are the responsibilities and job description for the Validation Engineer (Medical Device) position at TekOne IT Services Pvt. Ltd.?
Hello,
Greetings of the day.
This is Navya from Intellectt Inc. We have an opening for a Validation Engineer with one of our medical device clients. If you or anyone you know is interested in this opportunity, please send your updated resume to navyasri@intellectt.com or at 1 732 982 2113.
Job Title: Validation Engineer
Location: Plymouth, MN
Job Summary
We are seeking a detail-oriented and experienced Validation Engineer to join our team. The ideal candidate will be responsible for validating manufacturing processes and equipment under industry standards and regulatory requirements. This role is critical in ensuring that our products meet quality and safety standards in the medical device manufacturing sector.
Key Responsibilities
Greetings of the day.
This is Navya from Intellectt Inc. We have an opening for a Validation Engineer with one of our medical device clients. If you or anyone you know is interested in this opportunity, please send your updated resume to navyasri@intellectt.com or at 1 732 982 2113.
Job Title: Validation Engineer
Location: Plymouth, MN
Job Summary
We are seeking a detail-oriented and experienced Validation Engineer to join our team. The ideal candidate will be responsible for validating manufacturing processes and equipment under industry standards and regulatory requirements. This role is critical in ensuring that our products meet quality and safety standards in the medical device manufacturing sector.
Key Responsibilities
- Develop, execute, and manage validation protocols for equipment, processes, and systems in compliance with FDA regulations and ISO standards.
- Conduct process validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Collaborate with cross-functional teams to ensure that validation activities align with product development and manufacturing schedules.
- Review and approve validation documentation, including protocols, reports, and change controls.
- Identify and mitigate risks associated with manufacturing processes through effective validation strategies.
- Provide technical support and guidance to engineering and production teams regarding validation practices.
- Participate in internal and external audits related to validation activities and ensure compliance with regulatory requirements.
- Stay current with industry trends and regulatory changes impacting validation practices.
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- 3 years of experience in validation engineering, preferably in the medical device or pharmaceutical industry.
- Strong knowledge of validation principles, methodologies, and regulatory requirements (FDA, ISO 13485).
- Proficient in using validation software and tools.
- Excellent analytical and problem-solving skills, with strong attention to detail.
- Effective communication and interpersonal skills, with the ability to collaborate across teams.
- Experience with risk management techniques, such as Failure Mode and Effects Analysis (FMEA).
- Familiarity with statistical analysis tools and software.
