Specialist 2, Validation

Singapore, Tuas Singapore

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).

Key responsibilities:

  • Support day-to-day Validation activities in accordance with approved Validation SOPs / Plan / Policies for a large scale, multi-product, GMP biotech contract manufacturing facility.
  • Develop & execute Validation Protocols and Reports, including supporting site discrepancies and deviations investigation / closure.
  • Participate in Site Validation Maintenance Program.
  • Participate in commissioning activities when required.
  • Prepare and review Turnover / Vendor Packages & associated reports.
  • Support Change Implementation on site.
  • Support Validation / QA Audits as required, including Material Traceability Audits.
  • Support Customer / Agency Audits and Inspections as required.
  • Assist with implementation of department training requirements.
  • Assist Senior Specialist in the development of Validation Plans / Strategies for small to medium scale change implementation projects, including providing validation support where required.
  • Any other tasks as and when assigned by supervisor.

Key requirements:

  • Bachelor Degree with exposure in the Biopharmaceutical industry.
  • Relevant years’ of experience in Validation / Quality unit in the pharmaceutical/biotech industry.
  • Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP and ICHQ7).
  • Fair knowledge and experience of the practical and theoretical requirement of validation program in a GMP facility.
  • Good oral and written communication skills.
  • Meticulous and Systematic.
  • Team player, with strong focus on safety, quality and timelines.
  • Able to operate independently with minimum supervision.

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.

Reference: R44939