Nicholas Rollo Email & Phone Number

Bagsværd, DK

Somerset, NJ, US

Managed commissioning and qualification of a $192M aseptic fill/finish project following an immediate transfer to site. Quickly integrated within project team and site procedures to successfully conclude project. Supporting acquisition integration planning for site engineering and CAPEX projects.

Somerset, NJ, US

• Relocated to the BWI Harmans, MD gene therapy site to support audit readiness and to execute large CAPEX projects. Supported successful PAI audits in Baltimore and BWI with development and tracking of KPIs. Started the.
• Managed close-out of $267M gene therapy project at BWI Harmans, MD
• Completed $3.6M project for corporate office space and equipment training center
• Managed fire remediation inside of Manufacturing Cleanroom Suites at BWI Harmans, MD
• Managed inter-network equipment redeployment and warehouse auctions
• Completed ideation studies for site master planning, facility consolidation, aseptic fill/finish projects

Somerset, NJ, US

Managed the equipment design and procurement for a new Biologics site in Oxford, UK. Supervised concept thru detailed design of production cleanrooms and process utilities. Facilitated process knowledge transfer from Madison to Oxford sites.

Somerset, NJ, US

Managed the equipment design and procurement for a new Biologics facility in Anagni, IT. Supervised concept thru detailed design of production cleanrooms and process utilities. Facilitated process knowledge transfer between Madison and Anagni sites.

Somerset, NJ, US

• Completed the construction, start-up, and validation of a 2x4kL mAb production facility in Madison, WI. Responsible for overall project execution of facility and process equipment systems with total project cost of $83M.
• Responsible for weekly site updates and monthly reporting to executive leadership
• Managed the project change control draft, review, and approval process
• Directed the creation and execution of the commissioning project plan and commissioning test protocols
• Managed the draft, review, and approval process for facility and equipment URS’s

Beloit, Wisconsin, US

• PM and technical lead for the planning, design, construction, commissioning and qualification of NorthStar's 20,000 SF enriched-Molybdenum processing building expansion and accelerator-Molybdenum manufacturing facility
• PM responsibilities include:1) Daily communication with AE firms and general contractors2) Tracking change orders and presenting budgets to upper management3) Updating design and construction schedules in MS project.
• PM and technical lead for the facility design of NorthStar's Reclamation Suite, which reclaims enriched-Molybdenum in a Division I, Class 2 hazardous processing environment
• Attended ISPE's pharmaceutical water generation, storage and distribution courses for current industry practices and standards
• PM and technical lead for the design and installation of a 3-4 GPM WFI generation system with 40 GPM storage and distribution loop
• Attended an IOPQ training course to master current industry risk-based validation approaches as described by ICH Q9 Quality Risk Management guides

Brookfield, Wisconsin, US

• Daily experience in a Class I, Division 1 chemical manufacturing plant
• Executive assistant for design of peracetic acid food grade building
• Successfully applied for energy rebates to promote $60K chilled water insulation replacement
• Accelerated air permit renewal by modeling ~360 chemical processes with emissions software
• Explored lean manufacturing principles to justify installation of automated drum/tote filling system
• Improved roof fall protection for maintenance tasks with hatch guards and railings

Bachelors Degree, Chemical Engineering

High School Diploma