Leadership & People Management:
Leads and manages an area’s process systems within Biopharmaceutical manufacturing facilities on site.
Provides tactical guidance, arbitrates and prioritizes group activities, and implements resource loading and unloading for areas with
Coordinates and interacts Quality / Validation; QA; Manufacturing Science and Technology (MSAT) group; Facilities, Engineering, Maintenance; Environmental, Health & Safety (SHE); Manufacturing teams; Manufacturing Planners / Schedulers; Material Management group
Collaborates and assures strategic project target completions and technical competency in Stage Gate project reviews, Site Management and Stakeholders meetings, Product Councils and Steering Committees
Provides arbitration for the staffing and technical challenges affecting multiple System Classes
Be able to step in and act as a System Owner of any System Class in their area if required
Participates and provides guidance in Stage Gate project reviews, Site Management and Stakeholders meetings, Product Councils as related to the area of responsibility (upstream or downstream)
Provides mentoring and guidance to the team members as appropriate
Presents and participates in the industry-wide collaborative efforts (e.g. ISPE, PDA, AIChE) as relates to all aspects of the System Class design, installation, commissioning, operation, maintenance / inspection
Accountable for the System Class operational performance, availability, mechanical / structural / electrical integrity and reliability.
Strong ability to size, rate, select, and scale the process system components that include equipment, instrumentation, valves, and piping
Provides oversight and manages technical activities of area related studies, projects, and investigations, communicating the results to the Manufacturing Leadership Team
Manages and prioritizes System Owner’s response to emergent events that could interrupt production, while providing technical leadership to the initial assessment of events that have the potential to impact area safety and product quality
Coordinates and interprets operational data extracted from Batch Historian, through field observations, or compilation of study data, communicating the results to other groups and management
Accountable for the correctness of the Automation software updates and execution as it relates to the System Class
Initiates, coordinates, and approves the Root Cause Analysis and applicable troubleshooting for the System Class
Accountable and responsible for generation, review, approval, and life cycle maintenance of critical process requirement documents (e.g. Process URS, Process FS)
Accountable for correctness of project critical documentation (e.g. specifications, data sheets, calculations, P&IDs / PFDs, Vendor Drawings and Turn-over Packages) that may affect the System Class performance and integrity
Manages the development of area SOPs, protocols, as well other manufacturing documents
Coordinates Systems’ status, availability, and impact across all relevant projects and activities that may affect the system in technical, cost or schedule related manner
Provides oversight and approval to multiple projects implementation steps as it relates to the System Class
Bachelor’s Degree in Chemical or Bio-Chemical Engineering is preferred.
Degrees in Mechanical and Nuclear Engineering or equivalent operating experience along with a Bachelor of Science in relevant scientific disciplines is considered.
8-11 years of design and/or operational experience
Demonstrates a complete quantitative and qualitative understanding of process engineering principles and concepts with an ability to provide solutions to complex technical problems in the bio-pharmaceutical processing
Complete technical, design, and operational competence of specific System Class (es) within area of responsibility, and good understanding of complete Mammalian Cell Culture Process Upstream, Downstream, Process Supports and Utilities functions
Capable of providing creative, out of the box approaches to design and operating challenges
Proven ability to understand Project Management concepts and execution phases / deliverables for each phase
Working knowledge of applicable Quality Systems (e.g. Clean Utilities, sampling /QC)
Working knowledge of cGMP practices
Excellent written, verbal, and presentation skills with proven ability to use market available software