Sr Engineer Software Validation

Medline Industries, LP•Northfield, IL

21h•$101,000 - $152,000

About The Position

Job Summary 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, cleaning, facility, and utility system related 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. Know, support, and conform to Medline policies and relevant governing procedures. Maintain awareness to industry and regulatory environment, including FDA, GAMP, ISO. 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). Experience working in an AS400 environment. Preferred Qualifications: Work Experience Experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.). Experience with the following: 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 FDA Product and Establishment Registration GS1 / GUDID Management Quality Management System / Medical device environment experience. Additional Proficient in MS Word, Project, Excel. Experience in people and process management. Continuous improvement and Kanban related project experience 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. Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time. If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you. Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how Medline makes healthcare run better, visit www.medline.com.

Requirements

Bachelor’s degree in Engineering, Quality, Business, or Computer Science.
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.
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).
Experience working in an AS400 environment.

Nice To Haves

Experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.).
Experience with the following: 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 FDA Product and Establishment Registration GS1 / GUDID Management Quality Management System / Medical device environment experience.
Proficient in MS Word, Project, Excel.
Experience in people and process management.
Continuous improvement and Kanban related project experience

Responsibilities

Evaluate systems and applications to properly design organized and efficient software, process, automation, cleaning, facility, and utility system related 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.
Know, support, and conform to Medline policies and relevant governing procedures.
Maintain awareness to industry and regulatory environment, including FDA, GAMP, ISO.
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.