Lead Engineer, MSAT (CGT)

PVH (Tommy Hilfiger/Calvin Klein); Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

PVH (Tommy Hilfiger/Calvin Klein) is seeking a Lead Engineer, MSAT to drive technology transfer at the Singapore facility, collaborating with MSAT and customer experts to ensure timely, compliant transfer of manufacturing processes.

This office-first role emphasizes in-person collaboration with occasional remote work (about 20% of time). You will design experiments, prepare process documents, and support regulatory requirements while maintaining data integrity and continuous improvement.

Qualifications

• Experience with MSAT and tech transfer
• Hands-on sterile lab knowledge
• Strong documentation and analytical skills

Responsibilities

• Lead tech transfer of customer processes to Singapore facility.
• Collaborate with MSAT and customer experts on training, regulatory needs.
• Design experiments to support tech transfer and maintain data integrity.
• Prepare/process documents and CAPAs as required.

Skills

Cell culture knowledge

GMP/ATMP knowledge

Sterile manufacturing

Statistical data analysis

Problem solving (5 Whys/5M)

Lean Six Sigma

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related

Tools

Excel

TrackWise

Minitab

Job description

Overview

Lead Engineer, MSAT (CGT). The actual location of this job is in Singapore.

What you will get

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Daily company bus from the MRT location near your home to and from the Tuas site.
• Fully paid medical insurance, and option to enroll family members at partially subsidized premiums.
• Global benefits information available at the company website.
• This is an office-first role. Working together in person supports close, real-time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).

What you will do

• Technical transfer: Support the timely and successful transfer of customer manufacturing processes into the Lonza Bioscience Singapore production facility.
• Collaborate with MSAT team members, customer technical experts, and Lonza cross-functional teams on training, resource planning, pilot runs/engineering runs/study runs, and regulatory/compliance requirements.
• Coordinate with Manufacturing (training and resource planning), Supply Chain Management (material package review and BOM setup), Project Management (deliverables and communications), QA (regulatory/compliance), QC (sampling plan), Validation (equipment validation).
• Design and perform experiments on scaled processes in MSAT lab to support technology transfer; follow all applicable lab safety policies.
• Author and/or review process documents (Process overview, APS protocols, development/investigative protocols and reports).
• Develop and define training programs to facilitate integration of new manufacturing processes into the Singapore facility.
• Interact with customer technical experts as necessary to progress technology transfer.
• Process support: perform technical review of batch records, SOPs, deviations, change controls, training documents, protocols, development/investigative reports, and CAPAs.
• Support investigations into process issues/deviations, coordinate troubleshooting activities, and conduct experiments in the MSAT small-scale cell culture lab; follow lab safety policies.
• Manage change control implementation for process changes and coordinate non-GMP/non-clinical runs.
• Support pre-campaign preparation activities and provide oversight on the production floor to review operations and escalate issues as needed.
• Ensure alignment between trainings and process requirements; monitor run data for consistency; identify and drive process improvements.
• Support inspections and audits by customers and regulatory authorities; assist plant start-up and pilot/clinical/commercial runs and generate required change controls and technical reports.
• Recognize abnormalities and potential events affecting process, product quality, or safety; escalate promptly.
• Apply problem-solving tools (5 Whys, 5M, fishbone diagrams) to identify root causes.
• Uphold data integrity principles in accordance with Lonza policies and proactively improve data integrity processes.
• Other duties as assigned by your Manager.

Qualifications

• Extensive knowledge in cell and gene therapy, GMP, ATMP, and sterile/aseptic manufacturing.
• Hands-on experience in adherent, human cell culture techniques and equipment.
• Proficiency with Excel and statistical data analysis tools.
• Experience with TrackWise for change control, effectiveness checks, and CAPAs is highly desirable.
• Experience troubleshooting processing-related issues and/or equipment.
• Knowledge of Operational Excellence tools such as Lean manufacturing and Six Sigma.
• Additional information may be required to complete the profile; if you are interested, please apply to learn more.