Enterprise Solutions Specialist
Esco Lifesciences Group provides enabling technologies, products and services to the life sciences and healthcare industries, supporting academic research and scientific discoveries, clinical practice, as well as biopharmaceutical R&D and manufacturing. Headquartered in Singapore, Esco has an extensive sales network in over 100 countries, direct sales and service offices in over 24 countries, 8 manufacturing and R&D hubs in the US, Europe, the UK, China, Singapore, Indonesia, and over 1500 employees worldwide.
Esco is poised to benefit from the sustained growth of the healthcare and biopharma industries in Asia and globally. Esco has achieved market leadership in China, and globally, in multiple categories within some of the fastest-growing segments — with China being its largest and fastest growing market. As a Singapore-headquartered company, Esco is a nexus of East and West, bridging technologies, products and talent across the world, with global operations spanning the US, Europe and Asia.
Physical/Mental Requirements/Work Environment
- Ability to author or review standard operating procedures and other related documents.
- Ability to define problems, collect data, establish facts, and draw conclusions.
- Ability to focus.
You will be part of Esco Aster’s IT team and contribute towards the overall site mission and objectives. You will support the site’s GMP operational activities and laboratory compliance systems and support the qualification and validation of the company’s computerized systems.
Primary work location: Ayer Rajah Crescent, Singapore with some travel needed to Changi South Street 1, Singapore
Reporting to: Engineering/Automation, IT/OT
- Responsible for system administration and technical support/coordination of laboratory systems, including but not limited to LIMS, Empower, computerized and non-computerized lab equipment as well as systems maintenance related activities.
- Responsible for stability program administration and related activities such as stability chamber qualification and monitoring, stability data trending and report preparation.
- Responsible for lab equipment qualification, system development life cycle (SDLC) of computerized lab equipment and systems.
- Responsible to coordinate and plan for Lab system DI Remediation Plan.
- Implementation of a DI Gemba program for QC laboratories.
- Support Quality Controls Laboratories for DI Inspection Readiness / Inspection Responses.
(a) Including non-computerized systems.
- Provides support for laboratory testing of both developmental and commercial products as needed, and assists laboratories in lab investigation, troubleshooting and improvement of test methods as well as method transfer activities.
- Subject matter expert for the ongoing maintenance, improvement, and harmonization of laboratory systems and procedures related to analytical and quality control following GLP and ICH guidelines. For example, high performance liquid chromatography and other analytical instruments to USP, EP, BP, JP, CP country specific requirements within ASEAN.
- Point of contact for Quality Laboratories DI related matter.
- Provide support for cell line creation, process development, analytical development quality control and other ancillary laboratories for electronic data review and MIDAS Controlled Print implementation.
- Implementation of Electronic Lab Notebook and other related enterprise solutions working together with cross functional team comprising of scientists and lab managers.
- Lead the design and implementation of Lab system hardware and infrastructure.
- Perform technical operational support work and systems administration for Laboratories systems.
- Monitor, operate and enhance complex Lab infrastructure and computerized systems of distinctive platforms, including mid-range servers, and desktop computers, and instruments.
- Provide consultation with regards to software/systems implementation and validation on laboratories system.
- Provide hands-on operational support (technology, out-of-the-box configurations, process and content) for installed solutions.
- Author GxP business and technical requirements, use cases, process flow document, create robust test plans and scripts, execute testing, support user acceptance testing, and perform production rollout.
- Responsible for the data integrity and quality/compliance of the core informatics systems.
- Support the end user of laboratory software/systems, to assist in search, transformation and reporting of scientific data to customers and management.
- Perform high level system administration of Laboratory systems: managing the user roles, including their configurations, security rights and access rights.
- Perform other duties as assigned.
- A Degree in Life Sciences, Engineering or a related discipline.
- Laboratory related IT experience in a biotechnology or related medical field.
- Minimum 6 years experience with laboratory computerized systems and minimum 3 years of actual hands on lab experience.
- Exposure to cGMP and experience in computer system validation for lab equipment. Familiar and keeping up to date with current GMP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Able to work independently, self-starter, self-motivated and task oriented.
- Good communication skills and able to openly communicate and escalate any relevant issues.
- Strong team player to work with both internal and external stakeholders.
- Develop positive relationship with a strong set of interpersonal skills.
Apply now by submitting a Cover Letter and CV to [email protected].