- Represent the Consumable Validation group in a 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-13485.
- Initiate and execute controlled document change requests.
- Execute other related tasks assigned by the supervisor.
- Excellent interpersonal and written skills; highly effective communication, facilitation, negotiation and teamwork skills are required.
- Able to work in manufacturing environment where there might be possible exposure to loud noise.
- Able to identify components with different colors (using visual).
- A minimum of 5 years of related Validation experience in the life science industry (i.e. medical device/IVD, pharmaceutical, biotech).
- 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.
- Knowledge and application of statistical techniques as a decision-making tool and practical experience in use of statistical analysis software JMP highly desirable.
- 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.
- 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
- 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.
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Sr Validation Engineer - Singapore - ILLUMINA SINGAPORE PTE. LTD.
Description
Roles & ResponsibilitiesPosition Summary:
This individual will work in a dynamic team-oriented environment and has primary responsibility for defining, implementing and maintaining validation for manufacturing processes and systems. As a Sr Validation Engineer, you will have a strong process development or process engineering background and is able to work independently requiring minimal direction.
Additionally, this person will partner cross-functionally and cross-site with R&D, Quality, Facilities, Production, and other engineering groups to lead validation efforts, collaborate in developing validation strategies, and execute validation deliverables.
Position Responsibilities:
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Position Requirements:
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Experience/Education/Skills:
JMP
Troubleshooting
FDA
FMEA
Process Improvement
DMAIC
Manufacturing Processes
ISO
Process Validation
Value Stream Mapping
Audits
PFMEA
Product Development
Manufacturing
Commissioning
