The Opportunity:The Pharma Technical Operations (PT) Global MSAT & Engineering (PTT) group takes bold steps to modernize technical operations so Roche can deliver medicines for patients more quickly, efficiently and reliably. In partnership with PT colleagues, we shape and accelerate technology innovation and product lifecycle management for tomorrow, while standardizing and driving operational excellence in PT today.
The PTT - global Manufacturing Science and Technology (gMSAT) department focuses on technical support for commercial products in our internal and external drug substance and drug product network, implementation of new technologies, network standardization and distribution technologies.
Who you are:Equipment Design Finalization & Operational ReadinessAs a key technical steward, you will focus on driving the site toward operational readiness:
- Process Equipment Design Finalization: Collaborate closely with engineering firms and equipment vendor to finalize the detailed design, technical specifications, and ensure critical process configurations/functiobalities are correctly reflected on all core process equipment FAT & SAT protocols.
- End-to-End Aseptic Integration: Ensure the finalized equipment designs deliver flawless processing across all sterile unit operations: Compounding, Buffer & Bulk Filtration, Sterile Filtration, Aseptic Filling, and Visual Inspection.
- Automation & PAT Deployment: Partner with Automation, IT, and Global teams to drive the on-site implementation, testing, and deployment of advanced robotics, automated material handling, real-time data analytics, and Process Analytical Technology (PAT) tools.
- CQV Partnering & Execution: Provide expert technical input into Commissioning, Qualification, and Validation (CQV) strategies based on User Requirement Specifications (URS). Collaborate directly with external CQV service providers to review deliverables and actively participate in the on-the-floor execution of CQV protocols, troubleshooting equipment performance gaps to ensure a successful handover.
- Technology Transfer Setup: Define and establish the technical baseline for incoming pipeline products / molecules, ensuring the finalized facility and equipment capabilities are physically prepared to receive tech transfers seamlessly.
- SOP & Operations Partnership: Partner directly with the Operations team to co-author, review, and finalize unit operation Standard Operating Procedures (SOPs), ensuring they are delivered on time and technically accurate ahead of water runs and engineering batches.
- Workforce Readiness & Training: Serve as the technical lead for operator training initiatives; translate complex automated, PAT, and aseptic technical concepts into digestible training modules to support floor-operator qualification.
- Excellent Vendor, Engineering Firm & Contractor Management
- Excellent Project Management & Timeline Adherence
Technical Skills & Competencies- Domain Expertise: Recognized expert in aseptic processing and sterile filling drug product manufacturing, with deep technical knowledge spanning from compounding, buffer/bulk preparation, and filtration through to visual inspection.
- Equipment Design & Vendor Relations: Proven capability in finalizing technical design specifications with process equipment vendors and collaborating with external engineering firms to see concepts built.
- Hands-on CQV Execution: Experience partnering with external CQV service providers, with a proven willingness and capability to get on the manufacturing floor to execute testing, participate in FAT/SAT, and troubleshoot equipment during commissioning and qualification process.
- Automation, Robotics & PAT Savvy: Strong technical familiarity with advanced automation, automated visual inspection (AVI) systems, isolated filling lines, digital manufacturing tools, and the implementation/validation of Process Analytical Technology (PAT) applications.
- Sterilization & Decontamination: Deep technical understanding of core sterilization science, including cycle development/qualification and Vaporized Hydrogen Peroxide (VHP) decontamination technologies for isolators.
- Risk & Change Tools: Mastery of Quality Risk Management (QRM) tools, specifically FMEA, alongside a robust understanding of formal change control/implementation procedures in a GMP environment.
- Project Delivery: Excellent project management skills with a proven track record of being methodical, highly organized, and driving strict adherence to project timelines. Familiarity with Agile frameworks is a plus.
- Collaboration & Training Ability: Natural capability to partner across functional lines (especially with Operations and Quality teams) to communicate technical steps clearly for SOP creation and training execution.
Minimum Requirements:- Education: Advanced degree in a technical, engineering or scientific field.
- Industry Experience: 8+ years of professional experience in large molecule sterile production technology(prior greenfield start-up or major facility execution/expansion experience is highly preferred).
- Leadership Experience: 5+ years of matrix team leadership, cross-functional team leadership, or people management experience.
- You are willing to travel up to 20%
Relocation benefits are not available for this posting.
The expected salary range for this position based on the primary location of Holly Springs, NC, is $114,400 to $212,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits#LI-PK1
