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Sr Validation Engineer
2 months ago
About the Role:
We are seeking a highly skilled Sr Validation Engineer to join our team at Illumina. As a key member of our validation team, you will be responsible for defining, implementing, and maintaining validation for manufacturing processes and systems.
Key Responsibilities:
- Represent the Consumable Validation group in cross-functional project teams, ensuring validation requirements and deliverables are communicated to the teams.
- Develop and articulate robust strategies for validation of processes and systems through development and release of holistic validation plans.
- In collaboration with end users, process owners, Quality Engineers, and other team members, develop validation protocols and oversee execution of IQ, OQ, 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 the applicable technology 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 the internal procedures and applicable external regulations and standards, e.g. FDA QSR, ISO.
- Initiate and execute controlled document change requests.
- Execute other related tasks assigned by the supervisor.
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 including: FDA cGMP; ISO 13485, ISO 14971, IVDD, FMEA, Risk Analysis and Design Controls and relevant regulations and requirements.
- Demonstrated ability to accomplish goals in collaboration with cross-functional teams.
- Excellent interpersonal and written skills; highly effective communication, facilitation, negotiation, and teamwork skills are required.
- 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 a complex scope.
- Able to work in manufacturing environment where there might be possible exposure to loud noise.
- Able to identify components with different colors (using visual).
Preferred Experience/Education/Skills:
- A minimum of 5 years of related Validation experience in the life science industry (i.e. medical device/IVD, pharmaceutical, biotech).
- Knowledge and application of statistical techniques as a decision-making tool and practical experience in use of statistical analysis software JMP highly desirable.
- Experience with a high volume, consumable production process highly desired.
- Experience with product development processes and project management is a plus.
- Experience with quality and process improvement methodologies and tools (Lean, Six Sigma, value stream mapping, FMEAs, DMAIC) is desired.
About Illumina:
Illumina is a global leader in DNA sequencing and genomics. We are committed to expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.
Why Join Us:
At Illumina, we believe that everyone has the ability to make an impact. 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.