Key Skills

Job Description

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. Job Overview Instrumentation & Software specialist About Your Role We are searching for an Instrumentation and Software Specialist within a regulated laboratory environment. In this role, you report to Site Validation Lead and collaborate across departments. As Instrumentation & Software specialist, you undertake software and equipment validation activities to ensure reliability and compliance with company standards and regulatory requirements. You investigate validation approaches and troubleshoot problems for systems and/or performance processes. You are responsible for writing protocols, reviews, and technical reports for new and current computer systems and related validation procedures. You may assist in establishing, maintaining, and updating standard operating procedures related to global and local computerized systems and equipment, validation policies and training programs. Your Main Tasks You act as System Administrator and are responsible for regulatory compliant management of different software packages (e.g. system Accounts Management); You conduct/participate in validation activities (e.g. Process mapping, Risk Assessment, annual/periodic reviews); You conduct/participate in Change Control documents; You ensure that archiving of electronic data is performed in compliance with SOP’s, protocols and GLP regulations. You are supporting scientific and technical staff in troubleshooting of (potential) problems related to software, instrumentation and (e-)data integrity. You participate in site-level audits and inspections. You may represent site at global meetings aimed to harmonize CRL procedures and streamline global implementation of computerized systems. You provide expertise and assistance to technical and scientific staff and to site leadership. Job Description Your Profile: Requirements A successful candidate will be able to bridge between IT, laboratory operations, and quality/compliance, ensuring that computerized systems and instruments are reliable, validated, audit-ready, and fully compliant with regulatory requirements while effectively supporting scientific teams. Therefore, we require: Bachelor's or equivalent in a scientific discipline; Experience and affinity in computerized systems; Experience with working in a laboratory environment; Excellent communication and interpersonal skills; Capable of being autonomous and making effective decisions Strong organizational skills with the ability to maintain an overview across multiple workstreams. Proficiency in computer-based word processing, spreadsheet and presentation applications. Our Offer A stimulating work environment in well-equipped laboratory; The possibility to further develop yourself in this area of expertise; A competitive salary and participation in a variable compensation plan with annual payouts based on business performance; An open corporate culture in a pleasant and informal atmosphere; A full-time position (40 hours per week). Physical Requirements 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 [email protected]. 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. 235595

Core Responsibilities

Administer computerized systems and conduct or support software and equipment validation, risk assessments, process mapping, change control, and compliant electronic data archiving. Troubleshoot software, instrumentation, and data integrity issues; prepare validation documentation and support audits, inspections, and site or global system initiatives.

Requirements

Requires a bachelor's degree or equivalent in a scientific discipline, experience or affinity with computerized systems, and experience working in a laboratory environment. Candidates should have strong communication, decision-making, organizational, and computer application skills, and be able to work autonomously across multiple workstreams.

Benefits

• Variable Compensation
• 401(k)
• Paid Time Off
• Stock Purchase Program
• Health and Wellness Coverage
• Employee and Family Wellbeing Support
• Work-Life Balance Flexibility