Sr Engineer Software Validation

Regulatory Jobs; Illinois; On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a senior validation professional to lead development and execution of software and process validations ensuring compliance with FDA, ISO 13485, and GAMP 5 guidelines. You will manage multiple projects, craft validation strategies, and document protocols for quality systems and manufacturing environments.

The role requires 5+ years in manufacturing/quality/engineering with 3+ years in GAMP 5 computerized validations and experience in a medical device QMS.

Qualifications

• Bachelor's degree in Engineering, Quality, Business, or Computer Science.
• 5+ years of experience in Manufacturing, Quality or Engineering.
• 3+ years of experience in GAMP 5 related computerized system validations.
• Direct experience in a medical device QMS environment (FDA 21 CFR Part 820, ISO 13485, ISO 14971).
• Experience with software validation concepts, testing, and documentation.

Responsibilities

• Evaluate systems and applications to design validated software, process, automation, cleaning, facility, and utility validations.
• Design, develop, and implement test strategy, plans, scripts, and procedures to meet requirements.
• Manage multiple validation projects and communicate status to customers.
• Document validation protocols and reports with technical communication.
• Maintain awareness of FDA, GAMP, ISO regulations and industry standards.
• Improve efficiencies in software validation processes.
• Provide team support in validation initiatives and on-site facility support when needed.

Skills

Project management

Regulatory knowledge

Software validation

GAMP 5 familiarity

FDA 21 CFR Part 820 knowledge

AS400 experience

Willingness to travel

Education

Bachelor's degree in Engineering, Quality, Business, or Computer Science

Tools

AS400

MS Word

MS Project

MS Excel

Job description

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

MAJOR 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.

MINIMUM JOB REQUIREMENTS:

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.

Knowledge / Skills / Abilities:

• 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.
• Position requires travel up to 25% of the time for business purposes (within state and out of state).

PREFERRED JOB REQUIREMENTS:

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.

Knowledge / Skills / Abilities:

• 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 roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.

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.