1416 IT & Software Developer jobs in the US
Senior Software Validation Engineer
$101,000 - 152,000
Medline Industries, LP
Willow Road 888, Northfield + Remote
$101,000 - 152,000
Requirements
Must:
- Bachelors degree in Engineering, Quality, Business, or Computer Science.
- Minimum of 5 years of experience in Manufacturing, Quality, or Engineering.
- At least 3 years of experience with GAMP 5-related computerized system validations, involving design, authoring, execution, and coordination.
- Direct experience in a medical device Quality Management System (QMS) environment, including compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and principles of software validation.
- Knowledge of standard concepts, practices, and procedures within the realm of software engineering.
- Proven ability to influence, lead, and guide individuals across diverse functional areas.
- Experience in project management, including resource planning, organization, and effective completion of project goals and objectives.
- Strong interpersonal skills to collaborate efficiently with operations and larger IT teams on new software validation initiatives.
- Familiarity with AS400 environments; experience in validation for SAP is a plus.
Responsibilities
- Assess systems and applications to effectively design structured and efficient software, processes, automation, spreadsheets, and AI/Bot validations.
- Ensure validations are appropriately aligned with risk by designing, developing, and implementing testing strategies, plans, scripts, and procedures that meet requirements.
- Oversee multiple validation projects simultaneously, including collecting customer requirements and clearly communicating project status to ensure customer satisfaction.
- Prepare validation protocols and reports using proficient technical writing skills; knowledge of KNEAT validation lifecycle software is advantageous.
- Adhere to and support Medline policies and pertinent governing procedures.
- Stay informed about the industry and regulatory environment, including FDA, GAMP, and ISO, with a strong understanding of 21 CFR Part 11 requirements.
- Uphold organizational standards with respect to document control, quality records, attention to detail, and thoroughness.
- Identify opportunities to enhance efficiency in software validation and related processes.
- Provide team support for all validation efforts as necessary and assist division facilities on-site when required.
Description
At Medline Industries, we embrace a remote working model while requiring our team to be located in the Chicagoland area for occasional on-site demands. In this impactful leadership role, you will spearhead the development and execution of validation projects while ensuring compliance with customer and regulatory expectations. We offer a competitive rewards package, including health insurance, retirement contributions, and ample opportunities for professional growth within our rapidly expanding global organization. Our commitment to diversity and inclusion fosters an environment where every employee can thrive and grow in their careers.
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