Hi, greetings of the day,
This is Rajitha Kesam from Intellectt Inc., working as a Technical Recruiter. Currently, we have an immediate opening with one of our direct clients, please find the below Job description and if interested kindly do share your resume at
Position: Junior to Mid-Level Validation Engineer
Location: Multiple Locations (USA)
About the Role:
We are looking for a Validation Engineer who will be responsible for ensuring systems, equipment, and processes meet regulatory standards. This role is perfect for a junior to mid-level engineer looking to develop their skills in validation across industries such as pharmaceuticals, medical devices, manufacturing, and automotive.
Key Responsibilities:
- Develop and execute validation protocols (IQ, OQ, PQ) for systems, equipment, and processes.
- Conduct equipment and process validation testing to ensure compliance with company and regulatory standards (FDA, ISO, etc.).
- Perform validation for new and existing processes, identifying areas for improvement.
- Write, review, and approve validation documents, including reports and procedures.
- Ensure all validation activities are performed in accordance with standard operating procedures and regulatory requirements.
- Collaborate with cross-functional teams (Quality, Production, Engineering, etc.) to ensure smooth implementation of validation activities.
- Troubleshoot validation issues and provide solutions.
- Support audits and inspections by regulatory bodies or internal quality audits.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 1-5 years of experience in validation engineering in industries such as pharmaceuticals, biotechnology, or medical devices.
- Understanding of validation principles (IQ, OQ, PQ) and regulatory requirements (FDA, ISO 13485, cGMP).
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to work independently and collaboratively in a team environment.
Preferred Qualifications:
- Experience with automated systems validation or software validation is a plus.
- Familiarity with statistical analysis tools (e.g., Minitab).
- Previous experience supporting audits and compliance inspections.
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Thanks & Regards
Rajitha Kesamreddy
Technical Recruiter
Email:
Phone: 732-532-2478 Ext: 267