Director Process & Automation
BeOne Medicines
Full-time
On-site
Hopewell, NJ
$169,800 - $229,800 USD yearly
Operations
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Role Summary
Director Process & Automation. BeOne seeks an experienced professional to lead strategy, development, and implementation of automation technologies and digital solutions across manufacturing. Focus on improving process efficiency, regulatory compliance, and leveraging technology to accelerate drug manufacturing. Based in Hopewell, NJ.
Responsibilities
- Strategic leadership – Develop and execute the site's long-term automation and digital roadmap, aligning with operational excellence and innovation; support manufacturing and facilities teams in deviation/root cause analysis and regulatory inspections.
- Digital leadership – Champion Data Integrity, digital transformation, and Factory of the Future initiatives; partner with Global Technology solutions for manufacturing fit.
- Project Oversight – Manage planning, execution, and completion of complex automation and process projects, on time, within budget, and to quality standards.
- Process Optimization – Identify high-volume or error-prone processes for automation; redesign workflows and implement solutions (e.g., eBR, eLogs) to improve productivity, cost efficiency, and compliance.
- Technical Transfer – Include equipment qualification, process validation, and computer system validations.
- Hands-on experience with DCS, PLC, HMI/SCADA modifications relevant to cell culture, purification, filling, packaging, and OSD.
- Controls/process fault analysis and remediation.
- Vendor management – Develop and maintain external vendor relationships to identify, evaluate, and implement new technologies.
- Work in an industrial manufacturing environment with gowning, GMP, and strict regulations; collaborate with Automation teams at other sites.
- Self-sufficiency and proactive communication between departments; perform other assignments as determined by supervisor.
Qualifications
- Bachelor’s degree and 10+ years of biological process and automation in GMP manufacturing experience required; Master’s preferred with 8+ years.
- 6+ years of managerial experience in leading automation/engineering teams or projects.
- Experience with regulated environments (cGMP, OSHA, EPA); experience authoring SOPs and controlled documents; project management experience (5+ years).
- Strong PC literacy; MS Office; experience with software lifecycle methodologies, 21CFR Part 11, and GxP CSV.
- Experience with Rockwell DCS, DeltaV, Allen Bradley PLC, OSISoft PI, Siemens, and related control hardware; design, change management, and validation knowledge.
Skills
- Strategic planning and execution
- Digital transformation and data integrity
- Project management and vendor management
- Process optimization and automation design
- Strong communication and teamwork
- Ability to operate independently and mentor others
Education
- Bachelor’s degree in a relevant field; advanced degree preferred
Additional Requirements
- Travel up to 10% (project related)
- Experience in regulated manufacturing environments