Our client, headquartered in US with Basic research, discovery, safety and efficacy, clinical support, and manufacturing leading is looking to hire an experience Equipment and Validation Engineer.
This role will be based out of Singapore and to focus on the provision of technical guidance, planning, coordinating and resourcing validation projects on-site.
The key role is to ensures the qualification and validation of equipment, facilities, utilities and processes are carried out in accordance with GMP and ISO 17025 guidelines including the following responsibilities:
- Manage the full lifecycle for validation projects including but not limited to; delivering on time, to specification and ensuring the delivery of a quality validation project.
- Responsible for developing, preparing the installation of and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate, internal company standards and current industry standards
- Plan, communicate, coordinate and execute simple and complex projects and other sites by using planning tools like Gantt chart, and CPM models.
- Write or assist in writing of SOPs for Validation Projects.
- Participate in validation project meetings, workshops, training of staff and production of related documentation.
- Assist in evaluation of Systems from different vendors to submit Capital budgetary papers, and to recommend the most appropriate systems, based on User Requirement Specification, and/or other specifications as required from site management and project.
- Provide progress reporting and input into established project documentation.
- Manage direct relationships with key project stakeholders.
- Initiate projects to improve efficiency and productivity of the processes.
- Represent the Department in regulatory and client audits as required as a SME for systems.
- Assist Manager to perform investigation for the system to bring about process improvement or when required.
- Assist Manager to monitor and trend cost expenditure over a defined period for monitoring of cost effectiveness for the department.
- Maintains proper records and documentation of activities that are compliant with good documentation practices, continuous compliance ISO/IEC 17025, cGMP, PIC/S, ISPE Guidelines, WHO Technical Reports, Company global SOPs and other data integrity principles for all activities.
- To work closely with all departments to ensure the operation of a validated environment according to existing QMS and/or other regulatory requirements.
- Performs all functions as tasked with high degree of accuracy and strict adherence to company's quality requirements.
- Reviews aspects/areas for improvement within your own duties/responsibilities and make recommendations to your line manager for your own or team improvements.
- Adheres to Company Policies and Procedures.
- Undertakes any other duty or responsibility, at the request of your manager that may be required within reason within the remit of your role.
To qualify for this role:
- You will have a degree in Engineering, Biomedical Sciences or any related field.
- 3 - 5 years of relevant experience working in an ISO17025 / GMP environment is preferred.
- Understanding of IT is expected, related to installation of software, interface of hardware and software and basic administrative controls of Windows (Such as adding user groups) is preferred.
- Understand concepts and rationale, and execute System Commissioning, Qualification and Validation for systems as per requirements stated in ISPE GAMP 5 and USP <1058> document is preferential.
Interested parties please click "Apply Now" or send MS Format CV to Gina Ng (EA Reg no: R1110400) at gina.ng@peoplebank.asia
Peoplebank Singapore Pte Ltd, EA Licence Number: 08C5248.
Interested parties please click "Apply Now" or send your CV directly to Gina Ng (EA Reg no: R1110400) at gina.ng@peoplebank.asia.
Peoplebank Singapore Pte Ltd, EA Licence Number: 08C5248.
