Manufacturing System Engineer jobs in United States
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Planet Pharma ยท 5 days ago

Manufacturing System Engineer

Planet Pharma is seeking a Manufacturing System Engineer to create and document applications within a cloud-based manufacturing execution system called Tulip. The role involves collaborating with multiple teams to translate paper-based manufacturing processes into electronic form while participating in an Agile software team.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote
Hiring Manager
Shana Blanz
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Responsibilities

Work independently to specify, plan, design, develop, test and support software components
Contribute to project schedule generation including scope of work, duration of tasks, and order of execution
Monitor work progress against schedule commitments, reports progress to leadership in a timely fashion, including when work will not be completed according to schedule milestones
Propose solutions to maintain schedule milestones including prioritizing efforts and monitor scope creep
Work with team to establish necessary requirements specifications and test plans for software product validations
Responsible for translating requirements into design and implementation of well-structured and documented software components
Implement new software component designs or enhancements to existing software products; participate in the implementation of more complex subsystems and systems
Troubleshoot/debug issues within existing automation systems and implement modifications to resolve these issues
Participate in technical design reviews and code inspections
Insure adherence to development policies and procedures
Ensure compliance with regulatory requirements including 21 CFR part 11 requirements, quality standards, and conveys an expectation of high-quality software

Qualification

Tulip/Tulip CloudAgile software developmentC#JavaScriptSQL ServerMES developmentAutomation/Process ControlUX design focusIT infrastructure knowledgeFDA/ISO-regulated experienceQuality management system knowledgeCommunication skillsInterpersonal skills

Required

Require a BS degree in Computer Science, Process Engineering, Continuous Improvement, or a related Engineering discipline with software development experience
Application development experience using Tulip/Tulip Cloud is required
Minimum 3 years of relevant experience is required
Knowledge of software development in a process oriented/regulated environment and adhering to a quality management system
Experience with Agile software development
Knowledge of Automation/Process Control experience
Excellent written and oral communication and interpersonal skills are essential

Preferred

Experience in MES development
Experience working in an FDA/ISO-regulated environment
Experience with software languages including C#, JavaScript and SQL Server
Experience with Power BI
Software development with a focus on UX design
IT infrastructure/ hardware knowledge

Company

Planet Pharma

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Planet Pharma is a pharmaceuticals company.

H1B Sponsorship

Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)

Funding

Current Stage
Late Stage

Leadership Team

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Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
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Emma Morris
President, PPG Advisory Partners
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Company data provided by crunchbase