• Assisted clients with CapEx efforts and design deliverables to ensure well-structured and documented work for easier building, commissioning, and maintenance.• Collaborated with large AE firms to optimize project outcomes and enhance operational safety.• Utilized strong project management skills to streamline processes and deliver high-quality results efficiently.

Capital projects for Contract Manufacturing Organizations [CMO/CDMO] greenfield or retrofit capital expansions [CapEx]. Process support:- Assist with production-based balance developmentGMP utilities for process equipment- Support for architecturally led efforts- Time and material studies/ gap analysis/ utility sizing- Drawing drafts developed with remote CAD assets [redline as basis for CAD]- Process needs coordinated with subcontracted utility team(s)- CIP process definition- General arrangement development- Master Equipment List management- Vessel design good practices- Piping studies/ arrangements Original equipment manufacturer oversight:- Submittal review- Request for information resolution- Alignment with supporting utilities- User Requirement Specifications drafting- Early value engineering- Safety review and hazard analysis- Instrumentation and control interfacing with BMS/PCS via PLC network Construction support:- Observations on logistics, safety, and ergonomics- Schedule alignment- Commissioning, Qualification and Validation support- Factory and site acceptance test plan review and comment Means and methods:- Specification alignment- Drawing management [Procore, etc. logistics]- Cross-functional discipline coordination- Tagging, ISA & ASME-BPE alignment- Mentoring new team members [petroleum/chemical SMEs introduced to biopharma]- Mentoring existing team members [materials/methods, constructability, rigging, platform requirements, spatial relations]

Worked with the high purity stainless crew installing a spray dryer/bag filter for pharmaceutical service. Planned the details for successful installation of duplex feed module OEM systems (2x10k/2x11k+4x1k). Prepared pressure test and passivation plans for the gmp utilities (USP/CS) and feed modules/spray dryer systems. Integrating the check-out of the CIP with the passivation gave the customer team an opportunity to leverage critical milestones. Performed daily management and engineering tasks, logistical planning and wrangling.

Supported their team with closing open events, periodic assessments and CAPA.The purpose of this effort was to develop a pilot program to facilitate coordinated closure of open event investigations. Current procedures were the basis for new methods. The program included:Draft examples, discuss with team for input and improvementEquipment or system based approachActive event investigations would be summarized with statusIdentify appropriate corrective action plan(s) to match event(s)Root cause analysis investigationCritical versus non critical instrumentation calibration intervalsOut of tolerance response review Risk based assessment of instrumentation and controlsReview of standard operating procedures. Red line input for completion by system owners.CQV procedure reviews Possible checklist development to facilitate turnover of more complete first attemptsGuideline documents and templates to complement validated procedures and protocolsInitial work may be performed in Word and ExcelLater work would be integrated into Track wise following training

To evaluate a specific process transfer from traditional methods (G1) to single use (G2). Assess equipment and facility requirements to support a target pro forma with flexibility and scalability for expansion.Focus on equipment systems and structure of documentation at the front end will enhance the quality of the final form and function.This contribution followed three prior projects with that product.

This facility produces gene therapy products utilizing single use technology intended for commercial manufacture. Assisted their US and EU teams review select submittals and drawings for a building retrofit and capital expansion. The project format of design/build with multiple players required simultaneous review and requests-for-information from many teams. Found and helped resolve a few conflicts which kept the long lead items on schedule. Assisted with the tech transfer effort to define suite configurations and equipment supporting future production concurrent with assignment close out. Developed solutions to enhance their technology which were passed on to the new hires for completion. Several issues were flagged and corrected which kept the project on track for rapid completion and proper functionality.

Developed process diagrams, pipe/equipment arrangements and functional descriptions from pilot data. Produced a design which was scalable for multiple locations. Prepared arrangement studies, CAD diagrams and orthographic studies to facilitate discussions for better-best cost vs. optimization scenarios. Prepared budgetary specifications and arrangements for various equipment systems. Delivered process diagrams, functional descriptions, equipment and instrument lists for that scope. Configuration of circulation design offered substantial energy savings based on a novel. first principle approach. Presented this work to the team and managers via a series of power points.

Bristol-Myers Squibb Cadence Project Devens facility, Massachusetts Spring/Summer 2012This effort implemented controlled changes to enhance the media prep, seed reactors and 6 x 20k cell culture line, buffer prep and purification operations. This was a fast track project, schedule driven with construction access limitations due to ongoing production commitments. Lead the Design Qualification of piping isometrics, submittal review, P&ID management and field coordination of various construction and qualification activities. Identified and communicated issues to the project team using a paperless method to resolve open items at the design and submittal level before construction release. This helped to minimize punch list items.

Developed production based simulations for various scales. Prepared utility of CIP, process equipment, materials handling and staffing basis for each scenario. The model was kept current with each scale.Sized and prepared budgetary specifications for powder handling/blending/agglomerating equipment. Sized and specified air handling and powder management systems. Generated appropration grade costs and schedule for a fast track capital expansion to an existing facitly.Next anticipated phase would be to locate new green field site.

Assisted with the rebuild of a few fermentors and a CIP. Provided design review for two expansions. Assisted with SAP integration of legacy assets and documentation.Design/built a unique equipment system (URS development and detailed cost estimate for approval, preliminary design thru shop testing/delivery/commissioning/ SOP development/training, integration with rebuilt fermentors and CIP). The system exceeded performance expectations for the same cost in half the shedule.

Have assisted responding to RFQs when their engineers and project managers time was required to complete ongoing commitments.Provided subject mater exert opinion to their customers for onsite CIP assessment.Often had their team build or modify equipment systems for my clients.

As-built assistance for the transition. Organized the rebuild and re-install of two centrifuges. Helped with a tightly planned utility shutdown.Familiar with the site and team following time assisting BASF. Optimizing 5-CIP, contributing to process/construction management for CapEx retrofit.

Had worked with this product (BMP-7/OP-1) at Biogen and when transferring to Stryker. Assisted their team review and return submittals to the A&E/construction firms. Commited to be onsite daily (in hotel nightly) for duration. This project was the 3rd contribution for this product (OP-1/BMP-7) development: 1) as-built the pilot at scale suite 2) bid on the relocation 3) DQ the capital expansion.

Identified root cause of a site wide rouge event.Identified a scheduling glitch which allowed for faster, better, safer CQV.Committed to second shift, 8-day on, 5-day off commissioning team for CIP during the BioNow phase.Also identified a few as-built risks, utility situation CAPA and schedule resequencing/optimization opportunities.

Perfomed CIP cycle development during pilot plant build out and returned in '95 and 2001 to assist with the expansions. Coordinated the design build of several unique equipment systems.For the CapEx, my role was to assist their engineers close out design issues found as-built and to develop OEM solutions.

Assisted a team of engineers and manufacturing supervisors with review of the detailed design which they would later own and operate. This was a complete retrofit two suites to accomodate new perfusion bioreactors/supporting vessels and purification. Have been "called back" to provide similar service with these folks for expansions at other facilities/companies. Early identification of conflicts with the structural steel, controls philosophy and process vessel configurations was relayed to the AE via the customer. The necessary revisions averted catastrophic results.

Delivered and installed 2 new CIP systems, commissioned one of them. Optimized 5 existing CIP systems while in service. Retrofit a suite to support cell culture (10x5k & 5x450L vessels), organized the design and supervised the construction. Rebuilt 3 bioreactors (ABEC & MBR). As-built utility distribution. Misc. other tasks as requested.

As-built walk downs to document a suite before retrofit. Troubleshooting studies and concise reports. Close out investigations. Later participated in re-install of same process at another site. Afterwards, got called back for retrofit and expansion of that second site.

Bid, design/built projects for many food, beverage, brewers and biopharm customers. All work was performed over tight shutdowns or prefabricated for quick installation. Projects included: emergency field repairs, retrofit, installation or relocation of large vessels (up to 40k gallon), heat exchangers, pasturization systems (similar to kill systems), process/product stainless tubing, instrumentation, controls, filling lines, custom/portable blending systems, many CIP systems, centrifuges, etc.Knowledge gained from this position proved useful.

Supported pulp & paper mill expansion efforts. Often our deliverable would be order of magnitude or appropriation grade preliminary engineering studies with detailed costs.At SWEC, I rejoined the team from CTMain/Parsons following their mass exodus.

CTMain was purchased by Parsons. I worked with their pulp & paper division on domestic and international projects. Other assignments included construction completion, commissioning and training for their industrial wastewater treatment plant at the Appliance Park, General Electric - Louisville, KY.A substantial portion of the team migrated to Stone & Webster. I worked with the same team over a decade.

Projects in the pulp and paper industry were supported. Project lead on a recycled fiber plant. 7 months overseas construction completion and commissioning (CCC).Oversaw the tile and steel process vessel designs for a $1.2 billion (1983 dollars) capital expansion.Ran the CCC for General Electric Appliance Park industrial wastewater upgrade. The process and equipment were field modified to accommodate the unusual flows and characteristics.Multiple as built or retrofit assignments for small mills and facilities.