IT Labs System Specialist

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

This position will provide support for the IT Laboratory applications that enable the BeOne Hopewell US Site Quality functions. This individual will partner with SMEs to provide solutions that support day to day business operations and deliver strong customer service.

This role will work independently with some supervision and provide technical direction, and support in the areas of Quality Control laboratory systems and some manufacturing systems.

This is an onsite role based in the Hopewell Site, NJ.

This individual will have some experience in GMP change control, CAPA and investigations to support day to day operations; experience in software troubleshooting and working knowledge of data integrity principles.

Essential Functions of the Job:

• Administer and maintain IT systems related to GMP, including laboratory information management systems (LIMS), manufacturing execution systems (MES), and enterprise resource planning (ERP) systems.
• Maintain system documentation, including change control records, system configurations, and user manuals, in accordance with regulatory requirements.
• Provide support for various lab instrument applications.
• Provide technical support and training to users on GMP IT systems, facilitating user adoption and system optimization.
• Some hands-on experience or familiarity with Laboratory information management systems (LIMS), Waters Empower CDS, Mettler Toledo LabX, SoftMax Pro, Environmental Monitoring systems.
• Support the configuration, administration, and operational maintenance activities for site quality systems.
• Requires working in an industrial manufacturing environment including gowning.
• Support operations and ensure compliance with regulatory, corporate and site requirements.
• Troubleshoot and resolve technical issues, working with vendors as needed to ensure minimal disruption to operations.

Education Required:

• Bachelor’s degree in information technology, Computer Science, STEM or related degree.

Qualifications:

• Bachelor’s degree with a scientific / engineering / Information technology background.
• Minimum 2 years of relevant work experience in building, configuring, and supporting Quality Control systems.
• Some experience or familiarity with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV).
• Previous experience in a GMP manufacturing or operations environment.
• Some experience or familiarity with at least one of the following platforms: Waters Empower CDS, SoftMax Pro, MT LabX, Thermo Fisher LIMS, Environmental Monitoring.
• Strong communication and customer service delivery skills.

Supervisory Responsibilities:  

• N/A

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $102,200.00 - $132,200.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.