Validation Engineer IV

Validation Engineer IV#26-12700 Des Plaines, IL All On-site 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.

Main Responsibilities:

Works with a cross functional team to review qualification and validation documents which meet Client and regulatory requirements. Supports the complete qualification and validation process to implement new manufacturing FUE and automation, process, 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 closely related discipline is required OR relevant combination of education or experience. At least 5 years 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 relative professional work experience in Medical Device Quality/Pharmaceutical or in a regulated industry
• Detailed knowledge of

FDA, GMP, ISO

13485, and

ISO 14971

• Strong technical writing skills; Polished verbal and written communication skills.

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."