Deskripsi Pekerjaan
We are seeking a dedicated and experienced Senior Validation Engineer to join our dynamic team in Kuala Ketil. As a key member of our engineering division, you will ensure the integrity and compliance of our manufacturing processes and equipment. This role involves leading complex validation projects, ensuring that all Steris products meet rigorous global regulatory standards, including GMP and ISO requirements. You will collaborate with cross-functional teams to drive quality improvements and maintain the highest level of operational excellence.
In this position, you will be responsible for the oversight of validation protocols, from Installation Qualification (IQ) through Operational Qualification (OQ) and Performance Qualification (PQ). You will also be tasked with mentoring junior staff and developing robust Standard Operating Procedures (SOPs). The ideal candidate is a strategic thinker who thrives in a regulated environment and is committed to delivering safe and effective medical solutions to our customers worldwide.
Tanggung Jawab
- Lead and execute validation protocols for manufacturing equipment, utilities, and processes in strict accordance with cGMP, FDA, and ISO regulations.
- Manage the entire validation lifecycle, ensuring timely completion of IQ, OQ, and PQ activities.
- Develop, review, and update Standard Operating Procedures (SOPs) and validation master plans.
- Conduct risk assessments and root cause analyses to resolve quality deviations and non-conformities.
- Prepare and present comprehensive technical reports to management, quality assurance teams, and regulatory auditors.
- Collaborate with engineering, production, and quality assurance departments to support new product introduction (NPI) initiatives.
- Mentor and guide junior validation engineers and technicians on best practices and compliance requirements.
Kualifikasi
- Bachelor’s degree in Engineering (Mechanical, Electrical, or Chemical) or a related scientific discipline.
- Minimum of 5 to 7 years of progressive experience in validation engineering within the pharmaceutical or medical device industry.
- Strong working knowledge of 21 CFR Part 11, GMP guidelines, and regulatory compliance frameworks.
- Proven experience with electronic validation tools and document control systems.
- Excellent written and verbal communication skills with the ability to document complex technical information clearly.
- Ability to work independently in a fast-paced manufacturing environment and manage multiple competing priorities.
- Willingness to travel for off-site validations or audits if required.