Validation Engineer
2 weeks ago
Kleen-Pak Products Pte Ltd is a trusted manufacturer of premium wet wipes and liquid hygiene products, serving global brands across sectors including retail, healthcare, F&B, and more. Our production facilities in Singapore and Vietnam are certified to ISO 9001, ISO 13485, GMP, and MDR standards, ensuring the highest quality.
As part of our growth, we are expanding our capabilities to include OTC products and are working toward FDA certification to meet U.S. market requirements. We are seeking a Validation Engineer to join our Quality Assurance team, responsible for ensuring compliance with regulatory standards, overseeing validation protocols, and supporting continuous improvement initiatives across our manufacturing and product development processes.
If you are passionate about quality assurance and regulatory compliance and want to be part of a growing, innovative company, we encourage you to apply and be part of our dynamic team at Kleen-Pak
KEY RESPONSIBILITIES
- Develop, execute, and review validation protocols (IQ, OQ, PQ) for equipment, systems, processes, and software.
- Establish and maintain a Master Validation Plan (MVP) for both Singapore and Vietnam sites.
- Lead and document validation for manufacturing equipment and processes, ensuring compliance with regulatory standards.
- Review and enhance existing processes for raw material qualification and finished product validation.
- Work closely with the Microbiology and R&D lab team to validate test methods and equipment.
- Review and enhance the validation process for software systems, ensuring compliance with FDA 21 CFR Part 11.
- Manage change control processes and execute re-validation as necessary.
- Draft, revise, and maintain validation-related SOPs and train relevant personnel.
- Act as the Validation Subject Matter Expert (SME) during audits and inspections.
- Conduct risk assessments and implement effective risk controls.
- Drive continuous improvement in validation processes.
KEY REQUIREMENTS
- Degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or related discipline.
- 3–5 years' experience in validation roles within pharmaceutical, medical device, or OTC product manufacturing.
- Strong regulatory knowledge of FDA 21 CFR 210/211/820, EU MDR, and ASEAN Cosmetic GMP.
- Familiarity with microbiological and analytical method validation.
- Excellent documentation, problem-solving, and training skills.
- Hands-on experience in regulatory inspections is highly advantageous.
- Occasional travel may be required to support cross-site activities and audits.
FDA
Regulatory Compliance
Healthcare
Material Qualification
ISO
GMP
Microbiology
Chemistry
Biology
ISO 9001
Change Control
Training Skills
Manage Change
Analytical Method Validation
Manufacturing
Commissioning
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