Sr Applications Quality Engineer

· 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.

Responsibilities

Major Duties Description :

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 or data visualization tools 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.

Project Management

· Serve as technical expert or lead projects/programs and technical staff to develop, test and implement significant new product operational improvements or devices new approaches to problems at the division/business unit.

· Responsible for total project scope and completion within budget constraints and scheduled completion date. Accountable for successful and timely completion of all tasks/projects under direct and matrix control.

Further Tasks

· Support as needed the development of junior employees in software validation, system configuration, upgrades, documentation and execution.

Do you have experience in Productivity software?, Do you have a Bachelor's degree?, Bachelor's Degree in Computer Science and/or Life Sciences

Work Experience

· 5+ years of computer software support and/or related experience, · 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 software validation and assurance such as GAMP 5, 21 CFR Part 11, Annex 11, etc.

· Experience in application configuration

· Strong technical writing and general problem-solving skills

· Experience with eQMS such as MasterControl or Smartsolve

3.83.8 out of 5 stars Sturtevant, WI 53177 Hybrid work $50 - $55 an hour - Contract