Qualifications

Area	Qualification	Internal (I) ----------- Strategic Partner (SP)
Owner's Rep	Capital and expense budget planning/forecasting Project charter development Project justification, presentation and approval support Review of large EPC firm deliverables Management of internal facilities and engineering projects Laison between EPC firm and Owner Production planning, debottlenecking and consulting support Project charter development Coordination and review of 3rd party Commissioning and Qualification efforts New Product Introduction (NPI) commercialization support Product Re-introduction (PRI) support Internal staff augmentation (misc tasks)	I I I I I I I I I I I I
Project & Construction Management	Planning, scoping, estimating, budgeting, scheduling, execution, controls, reporting and closeout Construction sequencing and trade coordination Construction quality review Operating facility shutdown coordination Overall project team coordination/direction cGMP Change Control documentation and management Coordination between construction contractors and internal departments	I I I I I I I
Project Engineering (Process, Mechanical, Utility)	User Requirements Specification / Functional Requirements Specification / Detailed Design Specification (URS/FRS/DDS) development Process equipment design, specification and procurement: Reactors, Fermentors, Bioreactors, Homogenizers, Centrifuges, Buffer Prep/Hold, UF/DF skids, Chromatography Columns/Skids/Pool Tanks, Vial fill, Pumps, Heat Exchangers, Agitators, Dryers, Filter Press, Distillation Columns, Scrubbers, Dust Collectors, Flexible Containment Packaging Systems Utility system design, specification, procurement and troubleshooting: AHUs, Chillers, Air Compressors, Vacuum Systems, Dirty Steam Boilers, Heat Exchangers, Specialty Gas Systems - N2, Argon, O2, NH3, USP Water Systems, Clean Steam Generators, WFI Systems, Parts Washers, CIP Systems, Filtration Systems, Energy Reduction/Recycling Systems Overall multi-discipline engineering team direction and oversight	I I I I
Process Development & Engineering	Technology Transfer Facility process fit analysis Process scale-up and optimization Process batch sizing and mass balance Process troubleshooting Detailed fluid flow and heat transfer calculations and analysis	I I I I I I
Electrical, Instrumentation, & Controls	High voltage distribution system design Area classification assessments Instrumentation specification and procurement support Fire alarm system design and specification Controls system hardware specification and procurement support Controls system programming for DCS and BMS (PLC, Delta V)	SP SP SP I SP SP
Commissioning / Qualification / Startup Support	Factory and Site acceptance testing protocol development and execution Commissioning protocol development and execution cGMP equipment validation protocol development and execution Integrated commissioning and qualification team management	I I I I
Environmental, Health, & Safety	Regulatory assessments, compliance program development, document preparation and submittal: State and federal environmental regulations, including MACT, Title V, RCRA, EPCRA Air pollutant emission estimation, including VOC, HAP, and criteria pollutants Process mass balances for waste stream identification, including hazardous and waste water streams Pollution prevention support, including identification, execution, and evaluation of projects Project/process review and support for regulatory compliance Air permit application preparation, negotiation and compliance support VOC control system design and safety assessment PHA leadership and documentation Incident investigation and root cause analysis Facility audit support, including response to external audits Carbon footprint calculations	I I I I I I I I I I I
Civil / Structural	Equipment support pad design Building/pipe rack structural steel loading evaluations & new construction design	I I

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