Hello Everyone,
Greetings of the day.
This is Vydehi from Intellectt Inc. We currently 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 feel free to send your updated resume to or reach out to me directly at +1 732 355 7412.
Title: Validation Engineer
Location: Rensselaer, NY
Duration: 12 Months
Job Description:
We are seeking two Equipment Validation/Qualification Contractors to support an expansion project at our client’s facility. The contractors will be responsible for the validation and qualification of new fill-finish equipment and filling lines to ensure compliance with GMP standards. The ideal candidates will have extensive experience in IQ Installation Qualification) and OQ (Operational Qualification), as well as familiarity with commissioning activities. While PQ (Performance Qualification) experience is preferred, it is not mandatory. A background in GMP environments and Good Documentation Practices (GDP) is essential for these roles.
Key Responsibilities:
● Validation & Qualification: Perform and support IQ/OQ for new fill-finish equipment and filling lines. Ensure that all equipment is installed and operating according to design specifications and regulatory standards.
● Commissioning Support: Assist with the commissioning of new equipment, ensuring all systems and equipment function properly before starting the qualification process.
● Documentation: Prepare, review, and maintain detailed validation protocols, reports, and documentation in alignment with Good Documentation Practices (GDP) and GMP
regulations.
● Collaboration: Work closely with cross-functional teams, including engineering, quality, and operations, to ensure seamless integration and validation of new systems.
● Regulatory Compliance: Ensure that all validation activities meet GMP regulatory requirements, contributing to the safe and compliant operation of the facility.
● Troubleshooting: Identify and resolve issues that arise during the validation process, collaborating with the team to ensure all equipment operates within validated parameters.
Qualifications:
● Experience: 4-10 years of hands-on experience in equipment validation and qualification, with a strong focus on IQ and OQ. Experience with PQ is preferred but not mandatory.
● Industry Experience: Prior experience working in GMP-regulated environments is required, particularly in the pharmaceutical or biotech industries.
● Equipment Knowledge: Experience with fill-finish equipment and filling lines is essential. Prior experience qualifying other types of equipment is a plus.
● Commissioning Experience: Strong understanding of commissioning activities for new equipment and systems.
● Documentation Skills: Proficiency in Good Documentation Practices (GDP), ensuring
all validation activities are properly recorded and compliant with regulatory standards.
● Problem-Solving: Ability to troubleshoot equipment and processes during the validation
phase and effectively collaborate with technical teams to resolve issues