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 – ISO
  13485:2016 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.

Compensation and Benefits

The anticipated salary range for this position: $ - $ 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.

• competitive total rewards package
• continuing education & training
• tremendous potential with a growing worldwide organization
• health insurance
• life and disability
• 401(k) contributions
• paid time off
• access to Employee Assistance Program
• Employee Resource Groups
• Employee Service Corp

For a…