Sr Engineer Software Validation

Medline; Redmond (OR); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Employee Resource Groups

Job summary

A leading healthcare company in Redmond, Oregon is seeking a Validation Manager to ensure compliance with regulatory requirements through effective leadership in validation projects. Candidates should have over 5 years of experience in manufacturing, quality, or engineering, along with 3 years in GAMP 5 validations. The position offers a competitive salary range of $101,000 to $152,000 annually, health insurance, and additional benefits including 401(k) contributions. This role plays a crucial part in streamlining software validations and maintaining compliance throughout the project lifecycle.

Qualifications

• 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 is required.

Responsibilities

• Evaluate systems and applications for software validations.
• Document validation protocols and reports.
• Manage concurrent validation projects while communicating with customers.

Skills

Manufacturing experience

Quality assurance experience

Engineering knowledge

Project management skills

Leadership abilities

GAMP 5 validation experience

Education

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

Tools

MS Word

MS Project

MS Excel

Job description

Job Summary

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

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.
• Coordinate, execute, and report on validation plans for custom and off-the-shelf software.
• 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 of the 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 development and upkeep of Divisional SOPs as related to software use.
• Provide system design feedback to ensure compliance with regulatory and Medline standards throughout the software development life cycle.

Minimum Job Requirements

• Education: Bachelor’s degree in Engineering, Quality, Business, or Computer Science.

Work Experience

• 5+ years of experience in Manufacturing, Quality or Engineering.
• 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 principles 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 (e.g., planning, organizing, and managing resources to bring about successful completion of specific project goals and objectives).

Preferred Job Requirements

• Experience in Manufacturing, Quality or Engineering including four major validation subjects (e.g., Computer, Equipment, Cleaning, Process).
• 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.

Benefits

Medline Industries, LP, and its subsidiaries offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The role is bonus and/or incentive eligible. All employees are eligible for health insurance, life and disability, 401(k) contributions, paid time off, and additional benefits such as the Employee Assistance Program, Employee Resource Groups, and Employee Service Corp. for part‑time positions.

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. Medline will not pay less than the applicable minimum wage or salary threshold.

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.