Director Process & Automation

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:

The Director, Process and Automation Engineering is responsible for leading the strategy, development and implementation of automation technologies and digital solutions across manufacturing at Hopewell.  The role focuses on improving process efficiency, ensuring compliance with strict regulatory standards, and leveraging technology to accelerate drug manufacturing.  Reporting to this role is Automation, and Manufacturing Technology.  This role will be based in Hopewell, NJ and report to the Site Senior Director Facilities and Engineering.

Essential Functions of the Job:

• Strategic leadership – Develop and execute the sites long-term automation and digital roadmap, ensuring alignment with the overall business goals for operational excellence and innovation.  Provide support to manufacturing and facilities teams in areas of deviation/root cause analysis and regulatory inspections.  

• Digital leadership – Champion and drive Data Integrity, digital transformation and Factory of the Future initiatives at the site.  Partner with Global Technology solutions to ensure right fit for manufacturing.

• Project Oversight – Manage the planning execution and completion of complex automation and process related projects, ensuring they are delivered on time, within budget and to the required quality standards. 

• Process Optimization – Identify high-volume or error prone processes suitable for automation.  Spearhead initiatives to enhance productivity, cost efficiency and compliance by redesigning workflows and implementing solutions like eBR, eLogs, etc..

• Technical Transfer experience including equipment qualification, process validation, and computer system validations.

• Hands-on experience with modification of DCS, PLC, HMI/ SCADA software applications and equipment used in the manufacturing related to cell culture, purification, filling, packaging and OSD. 

• Participate and lead in controls fault or process fault analysis and remediation.

• Vendor management – Develop and maintain relationships with external vendors and partners to identify, evaluate and implement new technologies and solutions. 

• Requires working in an industrial manufacturing environment including gowning, GMP, and strict regulations. 

• Collaborate and work closely with Automation teams at other sites in China.

• 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.

• Any other assignments as determined by supervisor. 

Education / Experience Required:

• Bachelor’s degree and 10+ years of biological process and automation in GMP manufacturing experience required

• Master’s degree and 8+ years of biological process and automation in GMP manufacturing experience preferred

Supervisory Responsibilities:  

• 6+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

•  This role will build and lead a high-performing team of automation engineers and process engineers.  This includes providing mentoring, coaching, and career development to foster a culture of technical expertise. 

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

• Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). (6+ years)

• Strong experience with one or more of the following platforms: Rockwell DCS, DeltaV, Allen Bradley PLC, OSISoft PI historian, Siemens, Instrumentation and control panel hardware as required by the job.

• Strong experience with process and equipment design, change management, process and equipment validation. 

• Direct project management experience required.

Other Qualifications:

• Exposure to or direct experience with regulated environments (i.e. cGMP, OSHA, EPA).

• Previous experience in a manufacturing or operations environment.

• Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.

• Experience in managing small to medium-sized projects and outside vendors. Effective written and verbal communications skills. 

• Project management experience (5+ years)

Travel:  Up to 10% (Project related)

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

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 [email protected].