Lead Engineer, Drug Product Visual Inspection, Expat Opportunity in South Korea

This is a stellar Global Expat opportunity serving as technical SME for automated visual inspection for mammalian cell culture biologics manufacturing. This is a once-in-a-lifetime Expat leadership opportunity within the World’s Largest biologics CMO expanding to 720,000L total mammalian cell culture Drug Substance manufacturing capacity with fully automated Drug Product manufacturing capabilities. You will be charged with the following activities:* Serving as key technical SME for automated visual inspection for vials and pre-filled syringes (PFS).* Leading Recipe Development and Programming AVI equipment from vendors including Seidenader (Koeber Pharma), EISAI (Syntegon), Bosch, Syntegon, Innoscann and Optrel.* Identifying and implementing cost savings ideas, specifically efficiency improvements that increase equipment capacity.* Incorporating cGMP regulatory and safety compliance into all assigned projects’ scope and design.* Investigating deviations of high complexity, involving multiple departments, that occur on the manufacturing floor.* Performing root-cause analysis and identifying appropriate effective corrective actions.* Authoring and performing documentation, including SOPs, MBRs, Protocols, and Reports.* Leading technical improvement projects aimed at defect reduction, improved equipment reliability, better equipment utilization, and investigating common cause process variation.* Training operations colleagues on aspects of processes, inspection, and equipment operation.* Identifying and implementing cost savings ideas, specifically improvements to increase equipment capacity.* Developing and validation manufacturing processes for drug products, taking into consideration problems in the technical transfer to production.* Responsible for audit preparation, documentation, and follow-up for Inspection and Packaging within the DP BU.Preferred Candidate Background and Expertise:* 10+ years Biopharmaceutical or Biotechnology industry experience.* BS in Chemical Engineering, Chemistry, Biotechnology, Microbiology, Biology or related Life Sciences or Engineering field.* Experience in Manual, Semi-auto, and Automatic Visual Inspection with sterile drug product manufacturing processes.* Experience in programming and recipe development for AVI equipment from Seidenader (Koeber Pharma), EISAI (Syntegon), Bosch, Syntegon, Innoscann and Optrel.* Experience in validation of manufacturing drug product processes.* Experience ensuring cGMP compliance and knowledge of FDA, ICH and EU regulations.* Broad understanding of Aseptic drug product processes, filling procedures, freeze drying, packaging, etc.* Knowledge of drug product visual inspection and packaging processes, including validation engineering.*** Please note that this is a full-time Expat Opportunity Based in South Korea. It is not based in the US or remote from the US. A full Expat Benefits package is provided including a company paid apartment, international school tuition and relocation assistance. ***Expatriate Benefits Package:Competitive base salary, target bonus, retirement allowance and excellent medical benefits.Company paid luxury apartment in Songdo.International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools.Company paid airfares to visit the US (or country of origin).3 weeks of vacation time.Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levelsWork alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University.Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport.