General:
- Lead and support all cleaning validation activities for the Singapore facilities for Drug Product and Drug Substance
- Serve as SME and provide cleaning validation expertise to support the facility start-up and routine commercial manufacturing.
- Accountable for the timely and compliant completion of all cleaning validation related activities and milestones
- Plan, manage and coordinate cleaning validation activities with internal and external resources/stakeholders
- Track the cleaning validation deliverables and ensure adherence to schedule for client projects
- Develop and implement cleaning validation strategies for Clean In Place (CIP) and Clean Out Of Place (COP)systems.
- Lead cleaning validation projects such as development and optimisation of cleaning CIP cycles/recipes and / or cleaning COP cycles/recipes.
- Manage the process for periodic requalification of validated cleaning processes.
- Collaborate closely with colleagues within the Validation team and cross functional departments (QA, Manufacturing, QC).
- Author and review cleaning risk assessments, technical protocols and reports and supporting documentation as required.
- Identify requirements for laboratory studies/trials to support cleaning validation activities and to consult closely with manufacturing/QC to oversee the design and execution of studies (as required).
- Identify and implement improvements where feasible to cleaning processes.
- Lead the execution of cleaning trials and studies on the manufacturing floor.
- Provide on the floor support for troubleshooting cleaning related issues and lead manufacturing investigations into Cleaning Validation deviations.
- Will be flexible to take on additional tasks and responsibilities (other areas of validation) at the discretion of the Validation Lead.
Qualification:
Education
- Bachelor's degree or above in Engineering or Science discipline.
Experience
- Demonstrated experience in cleaning validation or related validation experience in cGMP environment (5 years as a guide)
- Demonstrated hands-on experience in execution of cleaning validation / cleaning verification is preferred.
- Familiar with pharmaceutical CIP, COP and processes in drug substance and / or drug product.
Skills
. In depth knowledge and experience of regulatory requirements and industry standards
. Excellent verbal and written communication skills in English.
. Able to work independently with limited supervision in a fast-paced environment as well as collaborate with others in a team.
. Be careful, conscientious and meticulous in duties or work.
. Display a good working attitude, strong work ethic, and willingness to follow leadership directives.
. Strong collaboration, self-motivation, communication, problem-solving and technical writing skills.
. Demonstrated knowledge of pharmaceutical technology and processes
This is a high-growth opportunity for a motivated individual in a fast-paced company. While starting as a key contributor, the successful candidate will spearhead new projects and mentor junior members.
