We are looking for someone who is adaptable and flexible, but who also knows the value of quality standards. Technically, you should have relevant validation related experience in pharmaceutical / medical device industries and shall be responsible for supporting the compliance in validation activities during product transfer, instrument manufacturing, quality improvement, process enhancement, cost reduction, engineering evaluation and system improvement. Being a Quality Engineer you shall also responsible for risk assessment, metric reporting, execution & commissioning of day to day sustaining and product validation activities. One of your challenges will be to think differently with your problem solving but maintaining compliance to our quality system.
All About You
Work with Site Validation team and Manufacturing and Engineering subject matter experts to prepare for and support FDA and other country-specific agency audits.
Review any new and existing processes against cGMP and ISO 13485 requirements for equipment, software, test method, and process validation and help determine when re-validation is required.
Ensure site/system validation program meets requirements of FDA (21 CFR Part 11 and 820), ISO (13485 and 14971), and IEC 62304.
Manage and/or assist with management of overall validation key metrics with the manufacturing site and report status/progress to Quality Site Head.
Support maintenance of validated state under Site Validation Master Plan and update Site Validation Master Plan as needed.
Participate in validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports.
Review and approve IQ, OQ and PQ protocols for product, processes, facilities, software and equipment within the facility.
Review existing validation reports and identifies gaps for compliance. Develop strategies and plans to close the gaps in an efficient and technical manner as needed.
Facilitate execution of validation protocols and review objective evidence for inclusion in validation reports.
Perform functional and process risk assessments in conjunction with Quality and Engineering subject matter experts.
Ensure proper compliance to documented procedures, work instructions, checklists, and templates for system and process validation.
Uphold expectations for quality performance, continuous improvement, quality systems, process controls, and infrastructure for critical sustaining parts and new products.
Collaborate with peers and stakeholders to identify opportunities for process improvement on manufacturing facilities, processes and equipment.
Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites.
Assist with documentation of nonconformances and process deviations.
Ensure that testers are trained on Good Documentation Practices and procedures for protocol execution and deviation resolution.
Assist with documentation and resolution of deviances that occur during validation.
Assist with determination of root cause, impact, and resolution of problems impacting production.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Experience in the medical device/IVD or biotech/pharmaceutical industry in process/system validation, equipment/test method/process validation, quality management, process controls, and continuous improvement methods.
5-7 years in manufacturing, quality assurance, and/or process validation in a regulated environment.
Excellent interpersonal, verbal and written communication skills.
Knowledge and working application of 21 CFR 820 and ISO 13485 requirements
Ability to multi-task and methodically manage projects in a fast-paced manufacturing environment.
Ability to communicate effectively across functions and organizational levels.
Intermediate to advanced experience with words processing and spreadsheets, charting, graphing tools and presentation tools.
Experience in failure investigation, technical report writing, data mining, trend analysis and statistical analysis
Strong analytical, problem-solving and decision-making skills; Certified Quality Engineer, or equivalent, is a plus
Familiar with statistical analysis packages, eg, JMP, Minitab.
Bachelor’s degree in Engineering or Biological/Life Sciences.
Illumina believes that everyone has the ability to make an impact, and 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.