Validation Engineer - Nutrition Plant - Casa Grande, AZ

Thornton Tomasetti; Casa Grande (AZ); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott’s Casa Grande, AZ Nutrition Plant is seeking a Validation Engineer to lead design qualification activities and develop validation protocols for new installations or major changes.

The role requires a Life Science or Engineering degree with 2+ years in quality/validation and strong knowledge of Design Control, GDP and cGMP. Proficiency in MS Office and experience with protocol writing are expected.

Qualifications

• Bachelor’s degree in Life Science, Engineering, or closely related discipline is required.
• 2+ years work experience in Quality, Validation, Engineering or related field in the food industry or industries with similar regulatory oversight.
• Familiarity with GAMP5 and FDA’s Computer Software Assurance initiatives are preferred.
• Proficient with Microsoft Word, Excel and Outlook for planning, reporting and collaborating.
• Experience in protocol writing and execution, closure of validation activities.

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 elevate 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.

Skills

Design Control

GDP

cGMP

Validation Protocols

Regulatory compliance

Microsoft Office

FMEA

Documentation

Education

Bachelor's degree in Life Science or Engineering

Tools

GAMP5

FDA Computer Software Assurance

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Job Description Validation Engineer – Casa Grande, AZ Nutrition Plant Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• 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.

Opportunity

The Opportunity This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Casa Grande, AZ., is one of Abbott’s leading nutrition manufacturing plants in the U.S., reflecting our commitment to innovation and excellence. But we’re more than just a company, we’re a family. Working here you’ll be part of a family that works together to make a difference and enhance the lives of millions worldwide.

Job 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 elevate 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.

Required Qualifications

• 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).
• Familiarity with GAMP5 and FDA’s Computer Software Assurance initiatives are preferred.
• Proficient with Microsoft Word, Excel and Outlook for planning, reporting and collaborating.
• Experienced in protocol writing and execution, closure of validation activities.

Preferred Qualifications

• 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.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality

DIVISION: ANSC Nutrition Supply Chain

LOCATION: United States > Casa Grande : Plant

ADDITIONAL LOCATIONS: WORK SHIFT: Standard

TRAVEL: No MEDICAL SURVEILLANCE: No

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Wear ear plugs, Work in a clean room environment

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/ and on Facebook at https://www.facebook.com/AbbottCareers.

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