Director Process & Automation
BeOne Medicines
Full-time
Remote friendly (Hopewell, NJ)
United States
$169,800 - $229,800 USD yearly
Operations
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Role Summary
Director Process & Automation — BeOne Medicines. Leading the strategy, development and implementation of automation technologies and digital solutions across manufacturing to improve process efficiency, ensure regulatory compliance, and accelerate drug manufacturing. Based in Hopewell, NJ.
Responsibilities
- Strategic leadership – Develop and execute the site's long-term automation and digital roadmap aligned with operational excellence and innovation; support manufacturing and facilities teams in deviation/root cause analysis and regulatory inspections.
- Digital leadership – Champion data integrity and digital transformation; drive Factory of the Future initiatives; partner with Global Technology solutions for manufacturing fit.
- Project Oversight – Plan, execute and complete complex automation and process projects on time, within budget and quality standards.
- Process Optimization – Identify high-volume or error-prone processes for automation; redesign workflows and implement solutions (eBR, eLogs, etc.) to improve productivity, cost efficiency and compliance.
- Technical Transfer – Equipment qualification, process validation, and computer system validations.
- Hands-on engineering – Modify DCS, PLC, HMI/SCADA software and equipment for manufacturing (cell culture, purification, filling, packaging, OSD).
- Controls fault and process fault analysis and remediation.
- Vendor management – Develop and maintain relationships with vendors to identify and implement new technologies.
- Work environment – Operate in an industrial manufacturing setting with gowning, GMP and regulatory requirements; collaborate with Automation teams at other sites.
- Communication – Maintain transparent cross-department communication; self-motivation and independence are essential.
- 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 degree and 8+ years of biological process and automation in GMP manufacturing experience preferred
Skills
- Strong PC literacy; MS Office (Outlook, Word, Excel, PowerPoint)
- Experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP CSV
- Experience with Rockwell DCS, DeltaV, Allen Bradley PLC, OSISoft PI historian, Siemens, instrumentation and control hardware
- Process and equipment design, change management, validation
- Direct project management experience
Education
- As listed in Qualifications
Additional Requirements
- Exposure to regulated environments (cGMP, OSHA, EPA)
- Experience in manufacturing or operations
- Experience authoring and reviewing SOPs, on-the-job trainings, and controlled documents
- Experience managing small to medium-sized projects and external vendors; strong written and verbal communications
- Project management experience (5+ years)
Travel
Up to 10% (Project related)