Area

Qualifications

Internal (I)
or Strategic Partner (SP)

Owners Rep

Capital and expense budget planning/forecasting

I

Project charter development

I

Project justification, presentation and approval support

I

Review of large EPC firm deliverables

I

Management of internal facilities and engineering projects

I

Laison between EPC firm and Owner

I

Production planning, debottlenecking and consulting support

I

Coordination and review of 3rd party Commissioning and Qualification efforts

I

New Product Introduction (NPI) commercialization support

I

Product Re-introduction (PRI) support

I

Internal staff augmentation (misc tasks)

I

Project Management &
Construction Management

Planning, scoping, estimating, budgeting, scheduling, execution, controls, reporting and closeout

I

Construction sequencing and trade coordination

I

Construction quality review

I

Operating facility shutdown coordination

I

Overall project team coordination/direction

I

cGMP Change Control documentation and management

I

Coordination between construction contractors and internal departments

I

Project Engineering
(Process, Mechanical, Utility)

User Requirements Specification / Functional Requirements Specification / Detailed Design Specification (URS/FRS/DDS) development

I

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

I

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

I

Overall multi-discipline engineering team direction and oversight

I

Process Development & Engineering

Technology Transfer

I

Facility process fit analysis

I

Process scale-up and optimization

I

Process batch sizing and mass balance

I

Process troubleshooting

I

Detailed fluid flow and heat transfer calculations and analysis

I

Electrical, Instrumentation & Controls

High voltage distribution system design

SP

Area classification assessments

SP

Instrumentation specification and procurement support

SP

Fire alarm system design and specification

I

Controls system hardware specification and procurement support

SP

Controls system programming for DCS and BMS (PLC, Delta V)

SP

Commissioning, Qualification & Startup Support

Factory and Site acceptance testing protocol development and execution

I

Commissioning protocol development and execution

I

cGMP equipment validation protocol development and execution

I

Integrated commissioning and qualification team management

I

Environmental, Health & Safety

Regulatory assessments, compliance program development, document preparation and submittal:  State and federal environmental regulations, including MACT, Title V, RCRA, EPCRA

I

Air pollutant emission estimation, including VOC, HAP, and criteria pollutants

I

Process mass balances for waste stream identification, including hazardous and wastewater streams

I

Pollution prevention support, including identification, execution, and evaluation of projects

I

Project/process review and support for regulatory compliance

I

Air permit application preparation, negotiation and compliance support

I

VOC control system design and safety assessment

I

PHA leadership and documentation

I

Incident investigation and root cause analysis

I

Facility audit support, including response to external audits

I

Carbon footprint calculations

I

Civil / Structural

Equipment support pad design

SP

Building/pipe rack structural steel loading evaluations & new construction design

SP

Industry Experience
Pharmaceuticals, Biotech, Semiconductor, Oil & Gas

Representative Clients
Roche, Amgen, Hospira, Napro BioTherapeutics, Mayne Pharma, PR Pharmaceuticals, Riobozyme Pharmaceuticals, Maxtor, Array Biopharma