Validation Engineer, Nutrition Plant — Impact & Compliance

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’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.