Computer System Validation Specialist

Job Description

Job Description

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Computer System Validation Specialist .

Job Description:

Job Title: Computer System Validation Specialist

** Job Type: Contract **

** Job Location: Sturtevant, WI **

** Work Schedule: Hybrid **

** Pay Rate: $ 55 Based on experience. **

Shift- Monday to Friday (8-5 pm)

** Education **
Bachelor's Degree in Computer Science and/or Life Sciences

** Work Experience **
5+ years of computer software support and/or related experience

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 **

1 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

2 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
3 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.
4 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
5 SOP Maintenance / Support Provide input in creation and/or review of internal operating procedures.
6 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.
7 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.
8 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.
9 Further Tasks Support as 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.
10 Remote work eligibility allows for hybrid work

** Technical & Functional Skills **
• Must be proficient in MS Word, Excel, and PowerPoint software programs. Required
• Must have excellent verbal and written communication skills and leadership skills Required
• Ability to work with company staff and communicate effectively throughout the organization is essential. Required
• Familiar with industry standards and Federal Regulations Required
• 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. Required
• Experience in application configuration Preferred
• Strong technical writing and general problem-solving skills Required
• Experience with eQMS such as MasterControl or Smartsolve Preferred

About Maxonic:

Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.

Interested in Applying?

Please apply with your most current resume. Feel free to contact Vidit Saini () for more details.

Company Description

Maxonic, Inc. is a certified minority-owned technology consulting and staffing firm founded in 2002. We provide technology consulting and staffing services to Fortune 500 companies across the country. We collaborate with clients to design, develop and implement business-driven technology solutions. We have deep domain expertise with multiple big data platforms and have strong partnerships with industry leaders in the space. The founders have over 40 years of experience helping clients and consultants succeed. Our commitment is to provide customers with an honest, personalized, face-to-face, long-term relationship and provide consultants with ethical, respectful, and stress-free care. We believe in the power of building successful careers for everyone.

Specialties:
Staff Augmentation
Professional Services - Artificial Intelligence, Big Data Analytics, Mobile Solutions, and Cloud Solutions
Outsourced Services, Administration and Support
Contingent Workforce Services

Company Description

Maxonic, Inc. is a certified minority-owned technology consulting and staffing firm founded in 2002. We provide technology consulting and staffing services to Fortune 500 companies across the country. We collaborate with clients to design, develop and implement business-driven technology solutions. We have deep domain expertise with multiple big data platforms and have strong partnerships with industry leaders in the space. The founders have over 40 years of experience helping clients and consultants succeed. Our commitment is to provide customers with an honest, personalized, face-to-face, long-term relationship and provide consultants with ethical, respectful, and stress-free care. We believe in the power of building successful careers for everyone. \r\n\r\nSpecialties: \r\nStaff Augmentation \r\nProfessional Services - Artificial Intelligence, Big Data Analytics, Mobile Solutions, and Cloud Solutions\r\nOutsourced Services, Administration and Support \r\nContingent Workforce Services