For 75 years, Charles River employees have worked to advance the discovery, development, and safe manufacture of new drug therapies, making a profound impact on global health. Our 20-year partnership with Boston Children’s Hospital takes this mission to the next level, supporting groundbreaking innovations that directly impact patient care. At Boston Children’s, their commitment to diversity drives the exceptional quality of care provided to patients from local communities to over 160 countries worldwide. This is your moment to become part of a family where unique talents and perspectives unite to change lives, including your own. Together, we’re shaping a healthier future through compassion, innovation, and opportunity.
This role’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 cGMP and ISO 17025 guidelines. This role is also expected to lead projects with various stakeholders and will be responsible for a small team to deliver results and projects for the site.
DUTIES AND RESPONSIBILITIES
- Manage and lead parts, if not all 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 leading, guiding and 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
- Lead, plan, communicate, coordinate and execute simple and complex projects within Charles River Singapore and other sites by using planning tools like Gantt chart and other Project Management Tools.
- Write or assist in writing of SOPs for Equipment and Facility related Validation Projects.
- Participate in validation project meetings, workshops, training of staff and production of related documentation.
- Lead 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 reports on Projects and communicate with relevant stakeholders.
- Manage direct relationships with key project stakeholders.
- Lead and self-initiate projects to improve efficiency and productivity of the processes.
- Represent the Department in client audits as required as a SME.
- Independently perform investigations as required and effective apply 6M or Ishikawa fishbone diagram, or any other applicable tools for Root Cause Analysis and evaluate practicality of actions to be applied.
- Able to communicate investigations succinctly and accurately.
- 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.
General requirements
- Maintains confidentiality of all Client information according to internal SOPs, Quality Service Agreements, and regulatory requirements.
- Actively seeks improvement within area of responsibility and takes necessary action to implement such improvements.
- Adheres to Company Policies and Procedures, including Code of Ethics and to Health and Safety requirements.
- Performs all other related duties as assigned.
- Education: Possesses at minimum, a degree in Engineering, Biomedical Sciences or any related field.
- Experience:
Minimum
- 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 required.
- 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 Insourcing Solutions
Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space.
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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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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