Senior Validation Engineer (NPI)

Early Applicant

5-8 Years

SGD 7,000 - 9,000 per month

Job Description

Provide quality oversight for validation, qualification, and equipment replacement projects within manufacturing environments
Review and approve acceptance test protocols and reports in line with applicable procedures and standards
Review and approve deviations, changes, and investigations related to validation and qualification activities
Collaborate with cross-functional teams to organize, plan, and ensure efficient execution of qualification activities
Lead and manage the product transfer process for new product introductions (NPI) and site-to-site technology transfers
Support implementation of future connectivity and digital validation strategies
Participate in continuous improvement of validation practices and documentation
Ensure compliance with internal and regulatory requirements during validation processes

Experience with process validation methodologies (IQ, OQ, PQ)
Experience in New Product Introduction (NPI) and managing technology transfers across manufacturing sites
Experience in equipment qualification and validation processes within pharmaceutical manufacturing
Experience reviewing and approving documentation (IQ/OQ/PQ, protocols, reports), deviations, and change requests
Knowledge of cGMP, GAMP, and relevant regulatory requirements
Understanding of quality risk management principles and validation lifecycle
Academic background: Bachelor's degree in Pharmaceutical Engineering, Life Sciences, or related field
Experience with CIP/SIP, Autoclave, and buffer preparation processes
You have excellent problem-solving and analytical skills, and an ability to work both independently and collaboratively with cross-functional teams