Technical* Expert Manufacturing Digital Support
Open for hire at one of the following locations – Singapore. - Job ID: 6331
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We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Technical* Expert Manufacturing Digital Support
This role is responsible in providing support to manufacturing digital systems such as Manufacturing Execution Systems (MES) used operations of drug substance (DS) and drug product (DP). This role ensures that the manufacturing systems are reliable, robust and fit for purpose, enabling efficient shopfloor operations.
Your main responsibilities:
- Participate in the design and validation (IQ, OQ, PQ) of MES and other relevant systems used in manufacturing zones
- Ensure that GMP documentation related to system implementation are complete
- First point of contact as Subject Matter Expert (SME) for MES matters
- Key partner to engineering automation team
- Design / Author relevant standard operating procedures (SOP) for manufacturing digital systems
- Design master batch record within MES, and perform required configurations to localise the system from global MES counterparts
- Work closely with DS/DP operations team to develop MES recipes that minimizes human error
- Collaborate with key functions within the site, more specifically with shopfloor biotechnologists, MS&T and engineering team during the project phase to ensure that the new transferred process is implemented successfully in the facility
- Build knowledge library for MES and other relevant manufacturing digital systems
- Provide training to shopfloor personnel on the use of MES and other manufacturing digital systems
- System owner for MES and other relevant manufacturing digital systems
- Drive investigations / troubleshooting for MES related incidents
- Improve / Optimise master batch record and other electronic forms design
- Manage change control related to MES or other relevant digital system changes
- Manage and mitigate key operational risks related to manufacturing digital systems
- Carry out duties as per assigned by Senior Manager / Associate Director, Manufacturing Support
What you have to offer:
- Degree in Information Technology, Computer Science, or equivalent field
- ≥ 7 years of relevant working experience, at least 3 years in biotechnology manufacturing industry
- Have basic knowledge in general biotechnology processes
- Extensive knowledge in digital tools used in manufacturing environment (MES, automation / DCS, historian, ERP etc)
- Experience with design, development, coding and testing of MES system
- Good knowledge of computerized systems, system administration and data management
- Good knowledge in computer system validation
- Experiences with collaborations with global multidisciplinary functions involved in digital system implementation
- Ability to be agile and effectively collaborate in a dynamic, cross-functional environment
- High degree of conscientiousness and diligence
- Constructive work habits, flexibility, solution orientation, job ownership, quality awareness, and very good planning and organizational skills in a fast-paced environment
- Self-starter and learning capacity
- Sense of ownership and honesty (proactive handling of errors)
- Ability to navigate through ambiguity and rapid growth and adapt to change, especially in a start-up environment
- Expectation to be hands on, interactive and display practical leadership
- Good communication skills
- Fluent in written and verbal English
Benefits for you:
We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.
How to apply:
Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.
Please note:
- Only applications sent via our online form shall be considered.
- Only Candidates with the right qualifications and relevant experience shall be shortlisted and
- Incomplete applications shall be rejected.
- BioNTech will run a background check during the hiring process
We are looking forward receiving your application.
*BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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