Engineer II, Process Equipment Engineer Small Molecule (Hopewell, NJ)

BeOne Medicines; Hopewell (NJ); On-site; USD 96,000 - 131,000; Full time

Job summary

BeOne Medicines, based in Hopewell, NJ, is seeking an experienced engineer to support a new small molecule manufacturing facility. The role ensures compliant operation of a 24x7 GMP facility and provides technical direction across equipment, commissioning, and validation with cross-functional collaboration.

The position requires a BS in Engineering or Life Sciences, 4+ years in GMP environments, and strong communication skills.

Qualifications

• BS or higher in engineering and/or related discipline.
• 4+ years of experience in GMP facilities/maintenance support or operations.
• Strong understanding of Quality in GMP environment including Good Documentation Practices, Deviation and CAPA management.
• Excellent communication and interpersonal skills, with the ability to collaborate across functional teams.
• Bachelor’s degree in Engineering, Life Sciences, or related field with 4+ years of GMP pharmaceutical experience required, or Masters degree with 2+ years required.

Responsibilities

• Provide SME input into Equipment and Facility for Small Molecule projects.
• Provide SME input for commissioning, qualification and validation of responsible systems.
• Develop and maintain technical, operational procedures, preventative maintenance plans for responsible systems.
• Work in cross functional team to hit project milestones and KPI’s.
• Manage the assets of buildings & facility, focusing on downstream equipment such as tablet press and coating machines.
• Directly support operations with troubleshooting and issue resolution.

Skills

Analytical problem-solving

Communication

Project management

Education

BS in Engineering

Life Sciences degree

Tools

Maximo CMMS

Microsoft Project

AutoCAD

Smartsheet

Power BI

Veeva Vault/eQMS

Job description

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

BeOne Medicines is seeking highly motivated and organized engineer, to join our team at the Hopewell, NJ site. The successful candidate will be responsible for supporting a new Small Molecule manufacturing facility and maintaining a stable, qualified, GMP manufacturing facility in close collaboration with the manufacturing and quality teams. The individual ensures reliable operation and state of compliance for a 24x7 commercial manufacturing facility. This role works independently, with minimal supervision and direction and will provide technical direction, Project Management support, Commissioning and SME expertise in the areas of oral solid dose manufacturing including blending, granulation, compression and encapsulation. Projects may often require independent decision making and exercising judgment. This role will be based in Hopewell NJ and report to the Senior Director Engineering.

Responsibilities

• Provide SME input into Equipment, Facility for Small Molecule project.
• Provide SME input for the commissioning, qualification and validation of responsible systems.
• Develop and maintain technical, operational procedures, preventative maintenance plans for responsible systems.
• Work in cross functional team with Global Engineering to hit project milestones and KPI’s.
• Work with external partners as required.
• Manage the assets of buildings & facility. Experience with small molecule drug product manufacturing equipment. With a focus on downstream equipment. For example, Tablet Press, Tablet Coating Machines, etc.
• Solicit and respond to user input with the team members and maintain positive relationships with all internal and external stakeholders.
• Directly support operations with troubleshooting and issue resolution with respect to equipment, facilities, and utilities.
• Participate and lead in fault analysis and remediation.
• Requires working in an industrial manufacturing environment including gowning.
• Other duties as assigned.

Experience Required

• BS or higher in engineering and/or related discipline.
• 4+ years of experience in GMP facilities/maintenance support or operations.
• Minimum of 4 + years of equipment and facility support in a GMP environment. Strong understanding of Quality in GMP environment including Good Documentation Practices, Deviation and Capa management.
• Excellent communication and interpersonal skills, with the ability to collaborate across functional teams.
• Proven ability to manage multiple complex priorities simultaneously under tight timelines.
• Analytical problem-solving skills and proactive decision-making.
• Ability to summarize and present project information clearly to management.
• Bachelor’s degree in Engineering, Life Sciences, or related field with 4+ years of GMP pharmaceutical experience required, or Masters degree with 2+ years required.
• Experience with CMMS, Metrology, and facility maintenance is required.
• People leadership, direct supervision required.
• The ability to operate self-sufficiently and to motivate oneself is crucial for the success of this position. In addition, the ability for this person to develop and maintain transparent communication between departments is essential.
• Experience with small molecule drug product manufacturing equipment, with a focus on downstream equipment (e.g., tablet press, tablet coating machines, etc.)
• Experience serving as an SME for equipment input
• Experience in Process Engineering for small molecule projects
• Other related requirements as applicable

Preferred Skills/Experience

• OE and/or LEAN Methodologies

Physical Requirements

• Ability to work in an office environment, construction site, and laboratory or manufacturing areas.
• Must be able to sit, stand, and use standard office equipment for extended periods.

Computer Skills

• Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook).
• Proficiency with CMMS, Maximo preferred.
• Experience with project management tools such as Microsoft Project, Autocad, Smartsheet.
• Familiarity with data management and visualization tools (e.g., SharePoint, Teams, Power BI).
• Ability to create and maintain Gantt charts, dashboards, and tracking templates.
• Comfortable working within document management systems (e.g., Veeva Vault, eQMS, or similar).

Other Qualifications

Demonstrates strong accountability, communication, and ability to build trust in a fast-paced, regulated environment

Travel

May require domestic travel up to 5% travel

Global Competencies

• 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: $95,600.00 - $130,600.00 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 [e-mail].