Sr Validation Engineer

7 months ago

Singapur, Singapore Illumina Full time
What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are 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.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Position 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 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.

Tasks and Responsibilities:

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.

​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:

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).

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:

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


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.

  • Sr. Solution Engineer

    7 months ago

    Singapur, Singapore Fortra Full time

    Problem Solvers. Proactive Protectors. Relentless Allies. Ready to join us? Let's get started. The Sr. Solutions Engineer, "Sr Presales Consultant," or "Sr Sales Engineer," is a technical role on the Sales team. It is an exciting opportunity for an experienced professional with strong technical, collaboration, and presentation skills. Someone who will focus...

  • Validation Engineer

    7 months ago

    Singapur, Singapore Snaphunt Full time

    The OfferA role that offers a breadth of learning opportunitiesJoin a well known brand within RetailFantastic work cultureThe JobYou will be responsible for : In charge of Cleaning ValidationSupport Wet Process processingEnsures the safety and purity of the product​Provides assurance that the cleaning method is robust and consistentAssures quality of the...

  • Validation Engineer

    6 months ago

    Singapur, Singapore Wood Full time

    A Pharma Validation Engineer is responsible for ensuring that pharmaceutical manufacturing processes, equipment, and systems comply with regulatory requirements, industry standards, and company policies. They play a pivotal role in the validation lifecycle, including planning, executing, and documenting validation activities to ensure consistent and...

  • Validation Engineer

    3 months ago

    Singapur, Singapore Amaris Consulting Full time

    Job description Mission Description: Write, review, and approve validation SOPs and documentation. Maintain accurate validation documentation for computerized systems. Train other staff members on the correct use of computerized systems in line with protocols and regulations. Plan, write, implement, and review the...

  • Validation Engineer

    4 weeks ago

    Singapur, Singapore NO DEVIATION PTE. LTD. Full time

    No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.We strongly uphold our core...

  • Cleaning Validation Engineer

    6 months ago

    Singapur, Singapore Amaris Consulting Full time

    Job description Amaris will be prioritizing applicants who are currently based in Singapore. Key Responsibilities: Develop and execute cleaning validation protocols for pharmaceutical manufacturing equipment and processes. Ensure compliance with regulatory requirements and industry standards for cleaning validation. ...

  • Validation Engineer

    7 months ago

    Singapur, Singapore PSC Biotech Corporation Full time

    PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract...

  • Process Validation Engineer

    4 months ago

    Singapur, Singapore Takeda Full time

    Description About the role: The individual will be expected to provide process validation support for Takeda vaccines manufacturing operations located in internal and CMO manufacturing locations. The process validation activities related to the vaccine manufacturing sites include, but are not limited to, the following areas: Oversight of Process...

  • Process Validation

    5 months ago

    Singapur, Singapore Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Sr Production Engineer

    7 months ago

    Singapur, Singapore NewMarket Corporation Full time

    Sr Production Engineer Location SG-Singapore Responsibilities 1. Supports Area Operation Manager in daily production activities to meet production schedules, EHS, quality and cost target. 2. Provides production and process optimization, trouble shooting, data analysis, and technical support to the operations organization. 3. Maintains...

  • Senior/Engineer, SSD Validation

    7 months ago

    Singapur, Singapore Micron Full time

    Our vision is to transform how the world uses information to enrich life for all. Join an inclusive team passionate about one thing: using their expertise in the relentless pursuit of innovation for customers and partners. The solutions we build help make everything from virtual reality experiences to breakthroughs in neural networks possible. We do it...

  • Sr. Engineer, NAND Cell

    7 months ago

    Singapur, Singapore Micron Full time

    Our vision is to transform how the world uses information to enrich life for all. Join an inclusive team passionate about one thing: using their expertise in the relentless pursuit of innovation for customers and partners. The solutions we build help make everything from virtual reality experiences to breakthroughs in neural networks possible. We do it...

  • Sr. Sales Manager

    3 months ago

    Singapur, Singapore Supermicro Full time

    Sr. Sales Manager Date: Oct 10, 2024 Location: Singapore, Singapore, SG Company: Super Micro Computer Job Req ID: 25228 About Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and...

  • Sr Software Engineer

    6 months ago

    Singapur, Singapore Micron Full time

    Our vision is to transform how the world uses information to enrich life for all. Join an inclusive team passionate about one thing: using their expertise in the relentless pursuit of innovation for customers and partners. The solutions we build help make everything from virtual reality experiences to breakthroughs in neural networks possible. We do it...

  • QC Validation Specialist

    4 months ago

    Singapur, Singapore NO DEVIATION PTE. LTD. Full time

    No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.We strongly uphold our core...

  • NVEG – NAND Silicon Design Validation

    7 months ago

    Singapur, Singapore Micron Full time

    Our vision is to transform how the world uses information to enrich life for all. Join an inclusive team passionate about one thing: using their expertise in the relentless pursuit of innovation for customers and partners. The solutions we build help make everything from virtual reality experiences to breakthroughs in neural networks possible. We do it...

  • Intern - Validation

    7 months ago

    Singapur, Singapore 825 Glaxo Wellcome Manufacturing Pte Ltd Full time

    Education required: Bachelor in Chemical Engineering / Pharmacy / Chemistry Other requirements: Must be enrolled at a University for the duration of your Internship Language requirement: Written and spoken fluency in English Expected Start Date: May/June 2024 Application deadline: We will close this vacancy when we have enough applications,...

  • NVEG – NAND Silicon Design Validation

    6 months ago

    Singapur, Singapore Micron Full time

    Our vision is to transform how the world uses information to enrich life for all. Join an inclusive team passionate about one thing: using their expertise in the relentless pursuit of innovation for customers and partners. The solutions we build help make everything from virtual reality experiences to breakthroughs in neural networks possible. We do it...

  • Graduate Verification

    4 months ago

    Singapur, Singapore Thales Full time

    Location: SINGAPORE, SingaporeIn fast changing markets, customers worldwide rely on Thales. Thales is a business where brilliant people from all over the world come together to share ideas and inspire each other. In aerospace, transportation, defence, security and space, our architects design innovative solutions that make our tomorrow's possible.Thales...

  • Engineer Internship

    7 months ago

    Singapur, Singapore ResMed Full time

    The Global V&V department operates as a borderless department with teams based in both Sydney and Singapore. Forming part of the product development team, the team ensures ResMed products meet our customers’ and patients’ needs as well as the regulatory and quality standards in various markets. Based from office location 1 FUSIONOPOLIS PLACE, #06-23,...