Validation Engineer
1 day ago
Overview:
Illumina is a global leader in genomics and genetic sequencing. We are committed to expanding access to genomic technology and making life-changing discoveries that transform human health.
About the Role:
We are seeking an experienced Validation Engineer - Process Expert to join our team. In this role, you will be responsible for defining, implementing, and maintaining validation for manufacturing processes and systems. You will work independently with minimal direction, partnering cross-functionally with R&D, Quality, Facilities, Production, and other engineering groups to lead validation efforts and develop strategies.
Responsibilities:
- Represent the Consumable Validation group in cross-functional project teams, ensuring validation requirements and deliverables are communicated effectively.
- Develop and articulate robust strategies for validating processes and systems through holistic validation plans.
- Collaborate with end-users, process owners, Quality Engineers, and other team members to develop validation protocols and oversee execution of IQ, OQ, and PQ for manufacturing processes and systems.
- Lead investigations or troubleshooting discrepancies/deviation encountered during commissioning and qualification.
- Write reports summarizing results and statistics for all equipment and process validation projects.
- Be accountable for timely completion of all validation deliverables in accordance with project timelines.
- Learn and understand applicable technologies and engage in technical discussions.
- Provide consultation to other departments performing validation activities.
- Provide input for creation of requirements documents.
- Actively participate in creation of risk management documents such as pFMEA for systems and processes.
- Participate as required in regulatory inspections/internal audits and develop strategies for key validation topics.
- Perform job function in compliance with internal procedures and applicable external regulations and standards.
Requirements:
- Knowledge and working application of FDA and cGMP requirements.
- Intermediate knowledge and working application of validation principles and guidelines and industry practice, FMEA, and Risk Management.
- Proficient knowledge and working application of standard operating procedures, as well as process and system validation principles for regulated industries.
- Demonstrated ability to accomplish goals in collaboration with cross-functional teams.
- Excellent interpersonal and written skills, highly effective communication, facilitation, negotiation, and teamwork skills.
- Computer competency in MS Office.
- Adaptable to fast-paced, dynamic work environment with ability to manage projects methodically.
- Familiar with the ALCOA concept.
- Demonstrated understanding and use of statistical methods in experiment design, data analysis, validation, and process monitoring.
- Demonstrated analytical problem-solving skills in self-directed manner and must be able to work on problems of complex scope.
- Able to work in manufacturing environment where there might be possible exposure to loud noise.
Estimated Salary: $120,000 - $150,000 per year
Why Join Us?
We believe 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.
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