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, genuinely improve the world. And that’s the kind of work we want to be part of.
Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.
The CSV Lead Engineer will provide day-to-day Validation activities support in accordance with approved SOPs / Policies for a GMP Biotech manufacturing facility. The role supports Validation activities related to computerized system and is responsible to ensuring their integrity, compliance and efficiency from a Computerized System Validation (CSV) perspective. The CSV Lead Engineer, will serve as site CSV Subject Matter Expert and lead day-today and project CSV activities. The CSV Lead Engineer will provide recommendation for improvements to the validation approach and site operations. The role will also collaborate with other site functions to implement improvements projects.
Key responsibilities:
· Lead or support day-to-day Validation activities in accordance with approved Validation SOPs / Plan / Policies.
· Develop & execute Validation Protocols and Reports, including supporting site discrepancies and deviations investigation / closure.
· Participate in system design review to ensure compliance to user requirements, good engineering practice, validation requirements and regulatory standards.
· Review and approve of Validation Protocols / Reports including site discrepancies and deviations investigation / closure.
· Participate in Site Validation Maintenance Program.
· Develop Validation Plans for a small to medium scale change implementation project and ensure the validation execution activity meets scheduled timelines.
· Coordinate with other Engineering functions, End-User and Quality team to ensure the Validation activities are completed as planned and are compliant to user, Lonza standard and regulatory requirements.
· Review Engineering documents associated with commissioning and validation activities.
· Evaluate and propose improvement to equipment/system, processes and operations to improve safety and process efficiency.
· Review & assess Site Change Controls and Validation CAPAs.
· Participate in Customer / Agency Audits and Inspections as required.
· Participate in on-job training program for Validation staff and provide training to as required.
· Any other tasks as and when assigned by manager.
Key requirements:
· Bachelor Degree / Diploma with exposure in the Biopharmaceutical industry.
· Relevant work experience in Validation / Quality /Manufacturing unit in the pharmaceutical/biotech industry.
· Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP and ICHQ7).
· Good knowledge and experience of the practical and theoretical requirement of CSV program in a GMP facility.
· Good oral and written communication skills.
· Meticulous and Systematic.
· Team player, with strong focus on safety, quality and timelines.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
