3452 IT & Software Developer jobs in the US
Engineer, Computer Systems Validation
$69,000 - 109,000
Thermo Fisher Scientific
Martin Luther King Jr Highway, Greenville
$69,000 - 109,000
Requirements
Must:
- Bachelors degree in Engineering, Life Sciences, Chemistry, or a related technical field
- Approximately 2 years of experience in validation, CSV, or a GMP-regulated setting is preferred
- Relevant internship, co-op, or academic project experience in validation or related industries is beneficial
- Basic understanding of cGMP regulations and validated environments
- Familiarity with automation/control systems such as PLCs, SCADA, DCS, DeltaV, or similar
- Ability to develop validation protocols including IQ/OQ/PQ
- Strong technical writing and documentation capability
- Knowledge of risk assessments and gap analysis basics
- Excellent analytical and problem-solving aptitude
- Effective communication and teamwork skills
- Capacity to handle multiple priorities in a fast-paced environment
- Proficiency in Microsoft Office software
Responsibilities
- Assess changes to current manufacturing systems, equipment, and associated databases
- Assist in change management for commercial production lines
- Create and implement validation documents including IQ/OQ/PQ protocols and qualification plans
- Conduct risk evaluations, validation assessments, and gap analyses to ascertain testing needs
- Collaborate with automation and engineering teams to qualify system modifications
- Aid in the validation of automation and control systems including PLC, SCADA, DCS, and DeltaV
- Ensure adherence to cGMP, FDA, and other industry standards
- Maintain thorough and compliant validation documentation
- Engage in continuous improvement efforts and operational excellence initiatives
Description
As part of Thermo Fisher Scientific, we offer the opportunity to engage in meaningful work that significantly influences global health, safety, and cleanliness. Our Pharma Services Group (PSG), based in Greenville, North Carolina, leads the industry in integrated drug development and manufacturing solutions for pharmaceutical and biotech companies. Our facility specializes in sterile and oral solid dose manufacturing, supported by advanced technologies in a cooperative team environment. We are committed to providing our team with the resources necessary to achieve both personal career objectives and collective scientific advancements.
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