Equipment and Validations Engineer

4 weeks ago

Singapur, Singapore Charles River Laboratories, Inc. Full time

For nearly 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Job Summary

 

This role's focus is on the provision of technical guidance, planning coordinating and resourcing validation projects on-site. He/She ensure the qualification and validation of equipment, facilities, utilities and processes are carried out in accordance with GMP and ISO 17025 guidelines

 

Duties and Responsibilities

 

  • Manage part of the 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 currnt industry standards
  • Plan, communicate, coordinate and execute simple and complex projects within Charles River Singapore 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 meetins, workshops, training of staff and production of related documentation
  • Assist in evaluation of Systems from different vendors for submission of 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 in improve efficiency and productivity of the processes
  • Represent the Department in client audits as required as a SME for at least 3 systems
  • Assist Manager to perform investigation for the system to bring about process improvement or when required
  • Assist Maanger 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 Line Manager for own or team improvements
  • Adheres to Company Policies and Procedures
  • Undertakes any other duty or responsibility, at the request of Manager that may be required within reason/remit of the role
Job Qualifications

 

  • Bachelor's Degree in Engineering, Biomedical Sciences or any related field
  • 2-3 years 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 Window (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 document is preferred
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
  • Effective communication and supervisory skills
  • Ability to organize and prioritize work to meet deadlines
  • Ability to read, write, speak and understand English

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. 

 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.

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