Sr Engineer Software Validation

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.

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 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.