Technical Specialist 3 (Deviation Investigation)

Lonza is the pioneer and world leader in the CDMO industry operating across 5 continents, setting the pace with cutting-edge science, smart technology and lean manufacturing. We turn our customers’ break-through innovations into viable therapies and manufacture the medicines of tomorrow. At the heart of every scientific breakthrough are talented individuals collaborating to develop solutions that empower businesses to improve lives. 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. As a Biotechnologist at Lonza Mammalian business, you’ll be part of our globally recognized network, driving the production of mammalian cell culture and treatments.

Join our best-in-class high performance Integrated Biologics team at our Tuas site in Singapore to gain unparalleled exposure to cutting-edge biotechnology and innovation, and make a difference from day one. Learn new skills and capabilities, and grow your career with us in manufacturing therapeutic proteins under cGMP conditions. Find out more about what a life at Lonza in Singapore could look like for you by watching this short video.

The Technical Specialist is responsible for performing Readiness, Release and Run aspects of Manufacturing Operations as assigned. This role will also be involved in driving continuous improvement initiatives within Manufacturing.

What you’ll 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, with the option to enroll family members at partially subsidized premiums.

The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits.

What you’ll do

Readiness

• Lead and support all tasks associated with operational readiness for technology transfers and process campaigns.

• Develop / revise the Master Batch Records (MBRs) in support of technology transfers/ process campaigns with technical information / instructions that meet the user requirements as well as approval of MBR template/ structures.

• Initiate and complete the change request prior to the start of a required process run.

• Support with creation / revision of risk assessments such as operational, safety and data integrity risk assessments.

• Support equipment, material or supplier qualification activities related to Manufacturing.

Run

• Prepare and support the assessment / rating of manufacturing deviations at the Deviation Review Board (DRB).

• Handle rejected materials through defective material inspections, review and assess vendor reports for operational improvements.

• Participate in Customer and Regulatory Audits to present relevant topics (e.g. Deviation, Change Requests, CAPA, etc.)

• Support with follow-up audit requests such as follow-up action from audits.

Release

• Lead investigations for deviations, non-conformities, trends and / or abnormalities which occur on product floor.

• Conduct root cause analysis using standard methodologies such as 5 Whys, Ishikawa Diagrams, causal branching, event and causal factor charting, Failure Mode, Effect and Cause Analysis (FMECA).

• Interact with customers in the form of face to face meetings  and / or teleconferences to communicate investigation findings / outcomes to the customer.

• Ensure timely investigation and closure of deviation reports in support of lot disposition.

Generic

• Additionally participate or lead and facilitate continuous improvement initiatives pertaining to Manufacturing Technical Team (MTT)  and / or Manufacturing operations.

• Collaborate interdepartmentally to drive assigned tasks to completion

• Perform other tasks assigned by your Lead / Manager.

What we are looking for

• Preferably a degree in Chemical/ Biochemical/ Pharmaceutical Engineering or Science.

• Over 5+ years of experience in Manufacturing or Biopharmaceutical processing, experience in Deviation Investigation and/or Technical Writing experience mandatory.

• Familiarity FDA & EMA GMP and regulatory requirements.

• Ability to lead and optimally facilitate discussion / projects in cross functional team

• Proficient communication abilities with internal and external customers

• Ability to lead projects under timelines

• Advanced knowledge in navigating through Controlled Document Management System (DMS) and Quality Management system (Trackwise)

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 sophisticated 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 relevant difference.