8 days old

Compliance Engineer

Illumina, Inc.
Madison, WI 53703
  • Job Code
    25594-JOB

Position Summary:

Provide Compliance support for assigned Facilities Operations, Validation, Engineering and Compliance at the Madison site. This position is responsible for supporting all Facilities equipment compliance activities conducted within Manufacturing and related Operations. Support in process improvement and global alignment Facilities compliance projects.

Responsibilities:

  • Assist facilities operations as needed in equipment management in the Maintenance Management System (MMS) such as equipment plan updates, onboarding, moving, and decommissioning of facilities equipment.
  • Support Facilities Calibration program through coordination with external vendors.
  • Collaborate with Facilities, Subject Matter Expert (SMEs) and stakeholders to write, create, and update detailed operational procedures and documents for Facilities.
  • Use Product Lifecycle Management software to complete tasks and drive closure of document and engineering record on behalf of the Facilities department
  • Collaborate within and across departments to collect and interpret input to be incorporated into documents.
  • Collaborate with Validation team to author and execute Facilities validation plans and IQ/OQ/PQ protocols for Facilities equipment.
  • Monitors Facilities departmental process metrics
  • Support implementation of the Facilities Change Control Process
  • Contribute to continuous quality improvement efforts to conform to regulatory requirements and industry standards.
  • Support in global document alignment and restructuring initiative.
  • Maintains awareness of standards that regulate our industry (ISO 13485: 2016; 21 CFR 820).
  • Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.
  • Ensures compliant documentation related to area of responsibility.
  • Implement approved action plan related to existing or missing documents

Skills

  • Experience in a cGMP environment is desired.
  • Ability to communicate clearly and professionally both in writing and verbally.
  • Flexibility in problem solving, providing direction and work hours to meet business objectives.
  • Ability to work independently and cross-functionally in a dynamic environment.

Education

B.A. or B.S. degree (preferably in Life Science or Engineering), and at least 2 years of experience in the medical device, pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf





Posted: 2021-06-08 Expires: 2021-07-07
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Compliance Engineer

Illumina, Inc.
Madison, WI 53703

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