Biopharmaceutical Automation Engineer
5 days ago
We are seeking an experienced Automation Validation Engineer to play a key role in the successful launch of our new state-of-the-art biopharmaceutical manufacturing facility. As a member of our team, you will have the opportunity to work on cutting-edge technologies and make a meaningful impact in the fast-growing biotechnology industry.
Key Responsibilities:
- Collaborate on IO checks, system integration, and validation activities to ensure seamless startup operations.
- Provide technical expertise to OEM engineers, facilitating smooth system integration.
- Participate in Site Acceptance Testing (SAT), Installation Qualification (IQ), and Operational Qualification (OQ) phases to guarantee efficient validation processes.
- Execute comprehensive test protocols, manage change controls, and address any exceptions that arise.
- Manage system backups, configure user groups, and develop training documentation for end-users.
Requirements:
- Bachelor's degree in Electrical Engineering, Chemical Engineering, or a related field.
- Proven experience in FDA-regulated environments, specifically in biotech, pharmaceutical, or medical device industries.
- In-depth knowledge of automation technologies, electrical control systems, and computer system validation (CSV).
- Familiarity with upstream and downstream biopharmaceutical processes.
- Proficiency in industry-leading tools such as Studio 5000 Logix Designer, FTView SE, and FTView ME.
Ideal Candidate:
- Strong analytical and problem-solving skills.
- Excellent communication and collaboration abilities.
- Ability to work effectively in a fast-paced environment.
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