Validation Engineer - GMP - HPLC- FDA Compliance

Position Details:

Position Details:

Industry:

Pharmaceutical/Biotechnology Job Title:

Validation Engineer IV (Pharma/Medical Device |

GMP, HPLC, FDA

Compliance)

Duration:

6 Months Contract (Possible Extension Based on Performance and Business Needs)

Location:

Des Plaines, IL 60018

Shift:

Monday-Friday | 8 Hours per Day |

Standard Business Hours Number of Positions Needed:

1

Pay Range :

$30.00 to $37.00 per hour

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 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 Qualifications:

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.

Additional Information:

Supports manufacturing expansion activities. Involvement in HPLC synthesis, purification, and testing. Engagement in change control projects.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - These all are subject to applicable eligibility).