Lead Biologics Process Specialist
We are seeking an experienced process specialist to drive biologics drug manufacturing processes and contribute to the development of our global operations.
About the Role:
This is a highly visible position that will involve collaboration with technical teams, key stakeholders, and cross-functional initiatives. The successful candidate will be responsible for overseeing project lifecycles, managing automation systems, integrating vendor-provided equipment, and implementing operational technology solutions.
Key Responsibilities:
* Project Oversight: Lead complex projects involving system integration, automation, instrumentation, controls, or manufacturing digitalization in the pharmaceutical/biochemical/biological industry.
* Automation Management: Manage automation systems, integrate vendor-provided equipment, oversee Building Management System (BMS), and implement OT applications.
* Qualification and Testing: Support in drafting documents, conducting design reviews, performing acceptance testing, and ensuring qualifications align with GAMP5 standards.
* Integration and Coordination: Drive functional commitment on projects, ensure seamless integration of automation workstreams at the site, and facilitate productive project meetings.
* Financial Management: Effectively manage project finances, forecasts, risks, change processes, and provide regular status reports.
* Risk and Problem Management: Facilitate risk and problem management, lead steering discussions, and actively encourage joint programs with key stakeholders.
* Post-Project Support: Coordinate the planning of system handover and provide post-project support to on-site engineering and maintenance teams.
* Continuous Improvement: Identify opportunities for continuous improvement and collaborate on joint programs with key stakeholders.
Required Skills and Qualifications:
* Bachelor's degree in relevant fields with a minimum of 10 years of experience in the pharmaceutical/biological industry.
* Familiarity with biologics drug manufacturing processes and key process equipment.
* Experience in projects involving system integration, automation, instrumentation, controls, or manufacturing digitalization in the pharmaceutical/biochemical/biological industry.
* Track record of leading complex projects and cross-functional initiatives.
* Familiarity with major DCS and working knowledge of BMS/SCADA/PLC systems.
* Strong customer service, coordination, and interpersonal skills.
* Good knowledge of GMP regulations.
* Ability to work across regions, time zones, and travel domestically and internationally.
What We Offer:
The opportunity to contribute to the development of our global operations and work with a talented team of professionals who share your passion for innovation and excellence.
We are committed to fostering a culture of inclusion, diversity, and respect. Our employees are empowered to make a difference and achieve their full potential in a dynamic and supportive environment.