Sr Engineer Software Validation

Job Summary

This is a remote role but will need to be based in the Chicagoland area as there will be requirements to come on site on an as needed basis.

Deliver leadership-level role in the development and execution of validation projects, ensuring customer and regulatory requirements are met in a timely and satisfactory manner

Job Description

Responsibilities:

• Evaluate systems and applications to properly design organized and efficient software, process, automation, spreadsheet, AI/Bot validations.
• Ensure scope and complexity of validations are commensurate with risk including the design, development, and implementation of test strategy, plans, scripts, and test procedures to meet requirements.
• Manage multiple, concurrent validation projects, including gathering and understanding customer requirements and effectively communicating project status to keep customer informed and satisfied.
• Document validation protocols and reports with professional and technical written communication skills. Familiarity with KNEAT validation lifecycle software a plus.
• Know, support, and conform to Medline policies and relevant governing procedures.
• Maintain awareness to industry and regulatory environment, including FDA, GAMP, ISO. Show sound understanding of 21 CFR Part 11 requirements.
• Maintain organizational excellence, including document control, quality records, detail, and thoroughness.
• Evaluate ways to streamline and improve efficiencies in software validation and associated processes.
• Provide team support in all validation initiatives as requested. Support division facilities on-site when needed.

Qualifications:

• Education Bachelor's degree in Engineering, Quality, Business, or Computer Science.
• Work Experience At least 5 years of experience in Manufacturing, Quality or Engineering.
• At least 3 years of experience in GAMP 5 related computerized system validations, including designing, authoring, executing, and coordinating.
• Direct experience operating in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principals of Software Validation, Electronic Records/Signatures.
• Additional Experience applying knowledge of standard concepts, practices, and procedures within software engineering.
• Experience and skills in influencing, leading and directing individuals in multiple functional areas.
• Experience with project management (for example: planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives). Interpersonal skills with ability to work well with operations and larger IT groups to collaborate on new software validations.
• Experience working in an AS400 environment. Experience with validation activities for SAP a plus.

Preferred Qualifications:

• Work Experience Experience in Manufacturing, Quality or Engineering including validation(software validation, manufacturing software validation, or QMS/ERP system validation):
• QMS - ISO13485:2016 - 21 CFR 820 QSR, 21 CFR Part 11 Electronic Signature, 21 CFR 801 Labeling
• GAMP Good Practice Guide: IT Infrastructure Control and Compliance (GAMP 5) ISO / Customer / Regulator Audits
• Solid understanding of FDA CSA Guidance (latest).
• FDA Product and Establishment Registration
• GS1 / GUDID Management
• Ability to understand new software function, requirements and evaluation software for validation. (Completing URS/FRS, Traceability matrix, IQOQPQ).
• Quality Management System / Medical device environment experience. Additional Proficient in MS Word, Project, Excel. Experience in project management a plus.
• Experience with equipment/process validation in pharma/Med Device a plus.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$101,000.00 - $152,000.00 Annual

The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.