Senior Equipment and Validation Engineer

Req ID #:  139196
Location: 

Singapore, SG

For 70 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

The Senior Equipment and Validation Engineer’s focus is on the provision of technical guidance, planning, coordinating and resourcing validation projects on-site. He/She ensures the qualification and validation of equipment, facilities, utilities and processes are carried out in accordance with GMP and ISO 17025 guidelines.

Job Qualifications

 

  • 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 within Charles River Singapore and other sites by using planning tools like Gantt chart, and CPM models.
  • Write or assist in the writing of SOPs for Validation Projects.
  • Participate in validation project meetings, workshops, training of staff, and production of related documentation.
  • Assist in the 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 the efficiency and productivity of the processes.
  • Represent the Department in regulatory and client audits as required as an 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 a high degree of accuracy and strict adherence to the 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.
     

Education: 

  • Possesses at minimum, a degree in Engineering, Biomedical Sciences, or any related field.
     

Experience:

  • Minimum 3 – 5 years of relevant experience working in an ISO17025 / GMP environment is preferred.

  • Understanding of IT is expected, related to the installation of software, the 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.
     

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
 

Others:

  • Effective communication and supervisory skills

  • Ability to organize and prioritize work to meet deadlines

  • Ability to read, write, speak and understand English
     

About Microbial Solutions
Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

 


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 17,000 employees within 90 facilities in 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. And in 2019, revenue increased to $2.62 billion.

 

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 ~85% of the drugs approved by the FDA in 2019.

 

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

 

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

 

For more information, please visit www.criver.com.


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