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Charles River Laboratories International
For 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.
The Principal Process Engineer will establish and maintain engineering for utility and process equipment and systems to support current Good Manufacturing Practices (cGMP) operations. This role will be responsible for management of equipment life cycle programs, tech transfer assessments and control systems for production equipment, QC laboratory equipment, utilities and data management systems in collaboration with other departments. This hands-on individual will possess a strong work ethic, the desire to work in a collaborative team along with a passion for creative thinking and problem solving. The role will be hands-on in collaboration with maintenance and calibrations activities between project teams, consultants, and contractors during new construction and on-going production. This position will oversee all stages of equipment and systems throughout its lifecycle including modifications, upgrades and maintenance. Incumbents will ensure compliance with all local and state safety requirements and create a zero-injury mindset at every level of the organization.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Manage all equipment life cycle deliverables (assessment, procurment, vendor relations, installation, maintenance program and decomissioning)
· Implement best practices for planning/scheduling and maintenance for utility and process equipment
· Maintain Building Management System (BMS) system and drive equipment utilization
· Manage and maintain site risk profile for equipment
· Provide technical expertise, direction, and guidance to problem solving efforts as required
· Lead technical discussions on complex system issues, makes recommendations, suggestions and report progress to site leadership
· Lead and/or actively participate in site cross-functional teams
· Create and execute comprehensive technical documents including SOPs, along with risk and lifecycle management documents for site, manufacturing and QC equipment as necessary
· Develop internal talent and ensure appropriate training is available to staff
· Ensure that all work is performed in compliance with SOPs, GMP, OSHA, and all other applicable regulations and company policies
· Recommend and implement enhancements to facility systems that result in improved quality performance, increased customer satisfaction, and/or simplification of processes to reduce costs
· Minimum of 12 years relevant experience in engineering
· Extensive knowledge of utility maintenance, metrology, building and preventative maintenance programs, cleanroom operations, water systems, and applicable regulations and local codes.
· Strong troubleshooting and problem-solving skills. Can lead or participate in issue resolution meetings.
· Strong interpersonal communication skills; ability to effectively communication (both oral and written) across all levels of the organization
· Demonstrated technical writing and clear documentation skills
· Ability to manage multiple and changing priorities and to quickly make decisions which protect our people, equipment, and facilities while keeping downtime and costs in mind
· Ability to interpret and apply GMPs, relevant laws, guidance and directives to sometimes complex situations
The pay range for this position is $144,800 – $161,800. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Biologics Testing SolutionsWith more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
About Charles RiverCharles 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 OpportunityCharles River Laboratories is an Equal Opportunity Employer – all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
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.
