Equipment & Software Specialist

Charles River Laboratories; 's-Hertogenbosch; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Stimulating environment

Professional development

Competitive salary with performance/RS

Open corporate culture

Full-time (40 hours)

Job summary

Charles River Laboratories seeks an Instrumentation & Software Specialist for a regulated laboratory environment. You report to the Site Validation Lead and collaborate across departments to ensure compliant validation of software and equipment.

You will write protocols, reviews and technical reports, support SOPs for computerized systems, and participate in audits and global harmonization of CRL procedures. Full-time role in a dynamic team.

Qualifications

• Bachelor's or equivalent in a scientific discipline.
• Experience and affinity in computerized systems.
• Experience in a laboratory environment.
• Excellent communication and interpersonal skills.
• Autonomous and capable of making effective decisions.
• Strong organizational skills with the ability to manage multiple workstreams.
• Proficiency in word processing, spreadsheets and presentations.

Responsibilities

• System Administrator with regulatory compliant management of software packages.
• Conduct/participate in validation activities (process mapping, risk assessment, reviews).
• Prepare and participate in Change Control documents.
• Ensure electronic data archiving complies with SOPs and GLP.
• Support staff in troubleshooting software, instrumentation and data integrity.
• Participate in site-level audits and inspections.
• Represent site at global meetings to harmonize CRL procedures.
• Provide expertise to technical staff and site leadership.

Skills

Communication skills

Autonomy / Decision making

Organizational skills

Laboratory experience

Regulatory/compliance awareness

Computer literacy

Validation basics

Education

Bachelor's or equivalent in a scientific discipline

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

• 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 [e-mail]. 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.