Sr Engineer Software Validation
About The Position
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. The position evaluates systems and applications and designs organized, efficient validations related to software, processes, automation, cleaning, facilities, and utilities. It establishes risk-appropriate validation scope and complexity, including test strategies, plans, scripts, and procedures. The role manages multiple concurrent validation projects, gathers and understands customer requirements, communicates project status, and prepares validation protocols and reports. It supports compliance with Medline policies and relevant procedures, maintains awareness of industry and regulatory requirements, and promotes organizational excellence in document control and quality records. It also identifies process efficiencies, supports validation initiatives, and provides on-site support to division facilities when needed. Travel up to 25% is required for business purposes, within and outside the state.
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 working in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principles of Software Validation, and Electronic Records/Signatures.
- Experience applying standard concepts, practices, and procedures within software engineering.
- Experience influencing, leading, and directing individuals across multiple functional areas.
- Experience with project management, including planning, organizing, and managing resources to achieve project goals and objectives.
- Experience working in an AS400 environment.
Nice To Haves
- Experience in Manufacturing, Quality, or Engineering covering four major validation subjects, such as Computer, Equipment, Cleaning, or Process validation.
- Experience with QMS – ISO 13485:2016.
- Experience with 21 CFR 820 QSR, 21 CFR Part 11 Electronic Signature, and 21 CFR 801 Labeling.
- Experience with the GAMP Good Practice Guide: IT Infrastructure Control and Compliance (GAMP 5).
- Experience with ISO, customer, or regulator audits.
- Experience with FDA Product and Establishment Registration.
- Experience with GS1 / GUDID Management.
- Quality Management System or medical device environment experience.
- Proficiency in MS Word, Project, and Excel.
- Experience in people and process management.
- Continuous improvement and Kanban-related project experience.
Responsibilities
- Evaluate systems and applications to design organized and efficient software, process, automation, cleaning, facility, and utility system validations.
- Ensure validation scope and complexity are commensurate with risk, including designing, developing, and implementing test strategies, plans, scripts, and procedures.
- Manage multiple concurrent validation projects, gather and understand customer requirements, and communicate project status to customers.
- Document validation protocols and reports using professional and technical written communication.
- Know, support, and conform to Medline policies and relevant governing procedures.
- Maintain awareness of the industry and regulatory environment, including FDA, GAMP, and ISO requirements.
- Maintain organizational excellence in document control, quality records, detail, and thoroughness.
- Evaluate ways to streamline and improve efficiencies in software validation and associated processes.
- Provide team support for validation initiatives as requested.
- Support division facilities on-site when needed.
- Travel up to 25% for business purposes, including within and outside the state.
Benefits
- Competitive total rewards package
- Continuing education and training
- Health insurance
- Life insurance
- Disability benefits
- 401(k) contributions
- Paid time off
- Employee Assistance Program access for employees working less than 30 hours per week
- Employee Resource Groups
- Employee Service Corp
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What This Job Offers
Job Type
Full-time
Career Level
Senior
