Mechanical Associate - Technical

Mechanical Associate - Technical Req ID #:  133374 Location: 

Neuss, DE, 41460 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

Responsible for all validation activities at Kaarst Site and other sites as needed. Responsible for developing and maintaining all documentation pertaining to validation and metrology. Serve as an information resource for validation team members, contractors, and vendors. Coordinate with other departments to ensure all aspects of assigned projects are achieved. Provide guidance to operational areas on all aspects of validation processes. Manage multiple projects and assist operational groups in the development of validation deliverables and use of project management tools. Job Qualifications ESSENTIAL DUTIES AND RESPONSIBILITIES:   Prepare a variety of engineering / validation project documentation, including business and functional requirements, design specifications, validation test protocols and technical support documentation. Execute test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate & site quality management system and current industry practices. Manage the full lifecycle of validation projects including defining and monitoring deliverable creation and timelines. Maintain and provide project timelines and statuses in project management tools. Coordinate cross functional teams involved in the validation project deliverables (e.g. Project Team, IT, Department Managers, vendors etc.) Coordinate project meetings, steering committees, workshops, and production of related documentation i.e. minutes of meetings, project plans etc. Effectively communicate project expectations to team members and stakeholders in a timely and clear manner. Report any non-compliances of Quality Management System with respect to validation to management. Participate in multi-site initiatives through document development or other validation activities. Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols]. Performs analyses and validate benefits related to selected projects. Develop and implement solutions to validation issues Present validation systems program during internal and external audits Perform all other duties as assigned.

QUALIFICATIONS: Education:  Bachelor's degree (B.A./B.Sc.) or equivalent in scientific or life-science engineering discipline. Experience: [(2-5) / 5+] years related experience in validation and qualification in both a GxP and ISO regulated environment. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Comprehensive knowledge of regulatory requirements, including GxPs, as they pertain to validation, is preferred. Excellent organizational and analytical skills and demonstrated ability to shift priorities to meet a constantly changing environment.

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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