Specialist 3, ENG Validation
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. 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.
Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.
The role is responsible to provide day-to-day Validation activities support (e.g. ongoing customer specific continued process verification, long term studies, plan/ generate/ execute at scale studies).
- Support day-to-day CSV activities in accordance with approved Validation SOPs / Plan / Policies for a large scale, multi-product, GMP biotech contract manufacturing facility.
- Develop & execute CSV documents, Protocols and Reports, including supporting site discrepancies and deviations investigation / closure. Validation documentation include but not limited to:
- Computerized System Assessments.
- Design Qualification/Reviews .
- Electronic Record and Electronic Signature Assessment.
- Data Integrity Risk Assessment.
- CSV protocols (IQ, OQ, PQ).
- Deviation reports which identify defects or issues during test execution.
- Reports which summarize the results of the protocol execution.
- Review design documents (e.g. FDS, HDS, SDS).
- Support Site Validation Maintenance Program (periodic review).
- Support Commissioning, SAT and FAT activities.
- Any other tasks as and when assigned by supervisor.
- Bachelor Degree with exposure in the Biopharmaceutical industry.
- Relevant years’ experience in Validation / Quality unit in the pharmaceutical/biotech industry.
- Familiar with Regulatory requirements and local Codes & Standards (e.g., cGMP, 21 CFR Part 11, EU GMP Annex 11, GAMP, and ICHQ7).
- Fair knowledge and experience with practical and theoretical requirements of validation program in a GMP facility.
- Fair knowledge and experience with Computerized systems (e.g. MES, DCS, SACDA, PLC).
- Pleasant personality.
- Good oral and written communication skills .
- Meticulous and Systematic.
- Able to operate independently with minimum supervision.
- Team player, with strong focus on safety, quality and timelines.
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 complex 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 meaningful difference.
Vaccination status: As the above role requires you to work on-site*, only fully vaccinated** employees will be shortlisted for the role. For fully vaccinated applicants, please indicate your vaccination status as “fully vaccinated” when applying for the role.
*In line with the latest advisory from the Ministry of Manpower, from 1 January 2022 only employees who are fully vaccinated or have recovered from COVID-19 within the past 180 days, can return to the workplace.
** Lonza adopts the definition of “fully vaccinated” by the Ministry of Health in Singapore which means that you:
(a) have received the full regimen of WHO EUL vaccines from a specific manufacturer; and
(b) have met the prescribed post-vaccination period for the respective vaccine to be fully effective.
We provide company transport, both ways, at multiple pick up points.