Validation Engineer IV

Title: Validation Engineer IV

Location: Des Plaines, IL

Duration: 12 Months

100% Onsite

Job Description:

• Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success for assuring high product quality and meeting business needs.
• Candidates must possess 7 or more years experience supporting validation programs and possess a BS degree, preferable in the Science or Engineering fields (or equivalent experience).

Main Responsibilities:

• Works with a cross-functional team to review qualification and validation documents that meet Abbott and regulatory requirements.
• Supports the complete qualification and validation process to implement new manufacturing FUE and automation, process, and test method validations in support of a manufacturing expansion.
• Especially in HPLC synthesis, purification, and testing. 
• Supports on-market change control projects.

Minimum Requirements:

• Bachelor’s degree in Life Science, Engineering, or a closely related discipline is required, OR a relevant combination of education or experience.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• Strong technical writing skills; Polished verbal and written communication skills 
• At least 5 years of work experience in Quality or related field experience.
• Has a history of completing successful projects and driving positive compliance outcomes.

Preferred:

• Bachelor's or master’s degree in one of the following Engineering disciplines: Chemical, Electrical, Bio-medical, or Mechanical
• 5+ years of relevant professional work experience in Medical Device Quality/Pharmaceutical or in a regulated industry

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

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, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.