QC IT Engineer

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

 

Consistently Ranked Science’s Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

  

 

 

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

  

 

Overview

Insmed is seeking a Laboratory Systems administrator/engineer with experience in computerized systems typically used within a lab setting at both a local and global implementation scale. This individual may be responsible for establishing procedures/protocols for management of laboratory software in Insmed laboratories and will coordinate activities across multiple sites. This role may assist in equipment software qualification/validation by serving as the software and data integrity SME. Additional duties will include collaborating with contractors and consultants to support design, configuration, customization and implementation of laboratory software systems including, but not limited to: Microtiter plate analysis software, CDS [chromatography data system], LIMS [laboratory information management system]. Assignments include analytical lab support required throughout the product lifecycle for all Insmed Programs.

Responsibilities

Representative responsibilities will include management of laboratory scientific software for analytical labs. Computer systems validation (CSV) experience is required. Experience authoring and executing CSV software validation scripts required. Experience authoring SOPs for (1) Software System Use and (2) Software system administration required. Experience with running and integrating the following software with other enterprise levels systems is required.Responsibilities:

• Administer, configure, and maintain the Lab system to meet the laboratory’s needs, including system updates, user management, and ensuring data integrity and security.
• Develop and maintain integrations between the Lab system and other laboratory instruments, systems, and databases to facilitate secure data exchange and workflow automation.
• Provide technical support to lab staff, resolving issues related to LIMS and associated systems promptly. Train users on new features and standard processes.
• Standalone Equipment software: QX Manager, Compass for Simple Western [BioTechne Jess], 32 Karat [Sciex PA800+], Softmax Pro [Molecular Devices plate readers], PLA for bioassays [Steggman System]
• CDS (chromatography database systems) such as Chromeleon and/or Empower.
• LIMS SME and Administrator: Labware LIMS with LIMS Basic coding experience a plus
• Statistical Program validation and administration—experience with JMP a plus
• Experience setting up procedural and physical controls for software that may not meet certain compliance standards.
• Experience authoring CSV related documents such as Gap Analyses, URS, risk assessments, etc.
• You may author and maintain a compliance checklist to guide the assessment process by cross-checking the company's performance against legal standards and identifying organizational gaps, weak points, and risks where adherence to rules should be tightened. May be involved in regular software audits to ensure compliance is maintained.
• Excel spreadsheet creation, use, administration and validation in a GMP setting experience is a plus.
• Maintain laboratory co