3391 IT & Software Developer jobs in the US
Requirements
Must:
- Bachelor of Science in Engineering, Automation, Computer Science, or equivalent
- Over 7 years of experience implementing CSV methodologies in operational IT, OT, and Automation in pharmaceutical, biotechnology, chemical, or food industries
- Strong familiarity with CSV regulations and software development lifecycle (SDLC) guidelines pertinent to life sciences
- Proven experience in Lab, Automation, and MES projects along with expertise in computer validation methodologies
- Proficient in creating, reviewing, and executing CSV documentation (IQ, OQ, PQ) and preparing for regulatory inspections
- Knowledge of Execution Systems technologies, including automated data collection, historian applications, SCADA, and connections to ERP, LIMS
- Understanding of industry standards regarding computerized systems and Electronic Records/Electronic Signatures (21 CFR Part 11, Part 820, Annex 11, GAMP5)
- Demonstrable experience in establishing and managing a CSV partner model within a regulated environment
- Excellent project management skills
- Ability to navigate regulatory compliance issues effectively
Responsibilities
- Develop and lead the site CSV strategy for Operational Technology (OT) systems, ensuring alignment with global standards
- Manage operational and Tier 2/3 CSV planning, resources, and delivery with external partners, including scope and priority setting across portfolios
- Create clear roles and responsibilities (RACI) and establish effective collaboration with site automation teams and external stakeholders
- Track partner performance against service level agreements (SLAs) and key performance indicators (KPIs), promoting ongoing enhancements in quality and compliance
- Support financial planning processes by providing expertise on upcoming resource needs
- Maintain the validated status of local OT platforms throughout their lifecycle by overseeing change control and validation strategies
- Collaborate with Quality and site automation to ensure that deviations and incidents relating to CSV/OT systems are thoroughly investigated and promptly resolved
- Implement governance routines to proactively monitor validated state risks and remediation strategies for site OT assets
- Maintain and update CSV documentation, including procedures, work instructions, and tools, in accordance with global standards and regulatory expectations
- Coach site automation teams and partners on CSV methodology to foster sustainable skill development
- Oversee vendor quality management system (QMS) integration and ensure compliance in documentation and testing practices
- Serve as the primary contact for regulatory inspections and audits related to CSV/OT, providing necessary documentation and evidence
- Drive ongoing self-assessments and audits to maintain inspection readiness for OT computerized systems
- Collaborate across functions to ensure cohesive CSV practices and provide training for site teams on CSV roles and expectations
Description
We are CSL Behring, a global leader in biotherapeutics, dedicated to saving lives through innovative technologies. We focus on developing and delivering therapies for various medical conditions across multiple therapeutic areas. As part of our commitment to patient care, we operate one of the worlds largest plasma collection networks, supporting the production of life-saving therapies in over 100 countries. Our team thrives on innovation and continuous improvement, fostering a culture of inclusion and belonging. Join us at our convenient location and enjoy our competitive benefits package designed to support your well-being and professional growth.
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You can find IT Specialist salaries in the United States here.
How many IT Specialist jobs are in the United States?
Currently, there are 3391 IT openings.
Is the US a good place for IT Specialists?
The US is one of the best countries to work as a IT Specialist. It has a vibrant startup community, growing tech hubs and, most important: lots of interesting jobs for people who work in tech.
Which companies are hiring for IT Specialist jobs in the United States?
D3 Security Management Systems, Gatestone & Co. Inc, Allied Technical Solutions, KUBRA, Agilus, GE Aerospace, Transport-Bourassa among others, are currently hiring for IT roles in the United States.
The company with most openings is Lockheed Martin Corporation as they are hiring for 268 different IT Specialist jobs in the United States. They are probably quite committed to find good IT Specialists.
The company with most openings is Lockheed Martin Corporation as they are hiring for 268 different IT Specialist jobs in the United States. They are probably quite committed to find good IT Specialists.
