Manufacturing Science Expert
6 days ago
About the Job
As a Manufacturing Science Expert at NNIT Singapore PTE. LTD., you will play a crucial role in ensuring the smooth operation of our clients' manufacturing processes. This position is ideal for individuals with a strong technical background and excellent communication skills.
Job Description:
We are seeking a highly skilled Manufacturing Science Expert to join our team. In this role, you will be responsible for performing risk-based commissioning, qualification, and validation services for pharmaceutical and biopharmaceutical clients. Your expertise will be utilized to develop risk assessments, system impact assessments, protocols, and reports that support the qualification and validation requirements in the industry.
You will also be responsible for developing validation protocols using a science and risk-based approach that meets regulatory requirements and industry best practices. Additionally, you will review, analyze, interpret, and summarize system and process performance data of executed activities for report and presentation to management.
Investigations into deviations, writing investigation reports, and creating summary reports will also be a key part of your responsibilities. You will exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Requirements:
- Bachelor's degree in a technical discipline such as Engineering or Science, or relevant experience in the field.
- A minimum of 3 years of experience in several functions in the pharmaceutical industry, including commissioning, qualification, validation, quality systems, quality operations, manufacturing, engineering, and technology transfer.
- Familiarity with ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4, and other regulatory requirements is preferred.
- Experience with investigations into manufacturing/laboratory deviations and determination of product impact potential, root cause, and corrective/preventive actions.
- Knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements, and industry best practices.
- Preferred experience in multiple CQV disciplines (such as CIP, SIP, process, utility, equipment, automation, computer system, lab system) with advanced technical knowledge in one or more discipline.
Benefits:
- Consulting roles with international healthcare clients in strategically relevant projects.
- Working in a professional consultancy environment together with a highly motivated team.
- Opportunity to take on leadership responsibilities and help shape our organization.
- Excellent career development and growth opportunities in a growing premier consulting organization.
- Structured training program and peer mentoring system to support competence and personal growth.
Estimated Salary: SGD $120,000 - $150,000 per annum
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