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Merz North America, Inc

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Sr Applications Quality Engineer (Biotech)



About Us

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

 
A Brief Overview

Responsible for development, implementation, and maintenance of Quality System applications and data visualization tools. This role will strategically align with business objectives to develop, implement, and optimize digital solutions that enhance operational excellence across quality and manufacturing processes. The role involves collaborating with cross-functional teams to plan, execute, and document CSV efforts, monitor validated systems, conduct periodic reviews, and manage related investigations. This role will ensure system support and maintenance of applicable business applications and data visualization tools are appropriately established. You will work with our business customers to ensure key technologies are delivering required value to the organization.

 

What You Will Do
  • Application Support and Management Ensure application support and management by establishing processes to manage user accounts, permissions, and security policies. Ensure appropriate level of technical assistance is available to users. Ensure process is established to troubleshoot issues and conduct training on new features and system use. Manage the handling of incidents until they are fully resolved, with a detailed analysis of the underlying causes provided. Monitor and maintain these technologies at optimal performance levels.
  • Application Development Responsible for gathering requirements and analyzing processes in order to recommend new technologies or improvements existing to quality system applications or data visualization tools. Interpret business requirements to functional designs. Configure and / or partner with external design engineers to configure applications which align with business requirements. Acts as the principal designer for major systems and their subsystems. Build and maintain multiple DEV, QA and production environments.
  • System Improvements Collaborate with key stakeholder on system upgrades and enhancements. Provide input to create a compelling roadmap for new technology and system upgrades. Create and maintain robust and validated processes for making changes.
  • System Validation Lead in the planning, development, and implementation of computer systems validation documentation and ensure compliance with required GxP and 21 CFR Part 11 regulations.
  • SOP Maintenance / Support Provide input in creation and/or review of internal operating procedures.
  • Compliance to Regulatory Requirements Assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to industry standards and federal regulations.
  • Quality Support Provide support for the Quality Assurance/Operations Departments and to other company departments as directed by Quality Systems Management. Serve as the CSV representative during regulatory inspections.
  • Further Tasks Support needed the development of junior employees in software validation, system configuration, upgrades, documentation and execution. Build relationships with end users and provide a positive working experience.
Minimum Requirements

  • Bachelor's Degree in Computer Science and/or Life Sciences.
  • 5+ years 5+ years of computer software support and/or related experience.
Technical & Functional Skills

  • Must be proficient in MS Word, Excel, and PowerPoint software programs.
  • Must have excellent verbal and written communication skills and leadership skills.
  • Ability to work with company staff and communicate effectively throughout the organization is essential.
  • Familiar with industry standards and Federal Regulations.
  • Strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, etc.
  • Experience in application configuration.
  • Strong technical writing and general problem-solving skills.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. Quality Systems/Customer Satisfaction

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