Validation Engineer Jobs

About The Position

Requirements

• Bachelor’s degree in Life Science, Engineering, or closely related discipline is required.
• At least 2 years work experience in Quality, Validation, Engineering or related field in the food industry or industries with similar levels of regulatory oversight such as laboratory diagnostics, medical devices, pharmaceutical, etc.
• Strong understanding of Design Control, Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP).
• Proficient with Microsoft Word, Excel and Outlook for planning, reporting and collaborating.
• Experienced in protocol writing and execution, closure of validation activities

Nice To Haves

• Familiarity with GAMP5 and FDA’s Computer Software Assurance initiatives are preferred.
• Self-starter with ability to achieve project goals with minimal management oversight.
• Act as a mentor and coach for a diverse team regarding validation, quality and compliance.
• Cultivate internal and external network of validation resources to complete tasks.
• Work independently and/or on project teams, with an ability to support a flexible work schedule.

Responsibilities

• Lead and support Design Qualification processes including; System Impact Assessments (SIA), Project Validation Plan (PVP), Failure Mode Effects Analysis (FMEA), and User Requirement Specifications (URS) for new installations or major changes.
• Develop, execute and review validation protocols and related documentation in accordance with procedures and policies
• Support resolution of validation events and escalate concerns in a timely manner
• Comply to all policies and standards
• Any other requests as assigned by supervisor
• You’ll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.