Instrument Software validation Engineer
TechClub Inc.
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Job Details
Skills
- Instrument
- validation
Summary
Role: Instrument Software validation Engineer
Location: Remote (Travel required on and needed basis to KY)
Job Description:
Key Responsibilities:
• Document and validate software installed on lab instruments per EMA regulatory standards.
• Validate Instruments and Instrument Integration
• Migrate instrument software management to align with PPD IT SOPs.
• Capture and document software requirements and configurations.
• Develop validation test cases and protocols related to Instruments/Medical devices, integrations and downstream workflow validation
• Create infrastructure and data flow diagrams.
• Conduct comprehensive risk assessments.
• Collaborate with cross-functional teams including IT, QA, and lab operations.
Required Skills & Qualifications:
• Proven experience in Instrument/Medical device validation along with integrations and downstream workflows within a regulated (GxP) environment.
• Strong technical writing skills for documentation and test case development.
• Excellent communication skills to interact with cross-functional teams.
• Highly detail-oriented with a focus on compliance and accuracy.
• Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings.
• Experience with risk assessment methodologies and validation lifecycle documentation.
- Dice Id: 90979514
- Position Id: 9020890
- Posted 4 hours ago
Company Info
TechClub Inc. renders avant-garde IT solutions to corporations. We provide exhaustive managed IT services that make us the perfect technology partners for our customers. TechClub Inc. is committed to designing critical information and maintaining a professional standard. We use cutting-edge digital approaches and maintain an open mindset to constantly innovate. Our objective is to guarantee customer satisfaction with our services. We are committed to providing post-implementation support and delivering expert IT solutions to over 50+ customers worldwide to improve and optimize operations.
TechClub Inc. was founded in 2014 and is based in Lincolnshire. We are a Google partner company, offering cost-effective, innovative, and sustainable web solutions with the slogan: “Imagination, Meets Implementation”. Our focused working strategy has made a considerable impact in the industry.
Mission
Our uncompromised, technology-agnostic guidance and implementation services are always delivered by senior IT leaders; we never razzle-dazzle and we never leave you with a solution we wouldn’t gladly support for the long run. Our commitment to customer results is unpaired in the industry – delivering unique attention and value to every client, every minute.
Vision
Our vision is to be a top player in the global market by accentuating constant innovation and delivering cost-efficient and typical IT solutions to our clients through technology leadership, creativity, and a devoted workforce.
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