United States
Sometimes the client relationship starts with helping key people complete lingering open tasks so they can focus on the new highly visible projects. Have assisted defining and steering high-stakes and low-key projects, I have become a trusted advisor in the realm of capital expenditure and process engineering. My journey has led me to my current role as an Independent Business Owner at EFH, where I am dedicated to aiding scientific clients in achieving well-structured and safe operational systems. My competencies are deeply rooted in project planning, budgeting, and skilled negotiation. Assisting AE's and original equipment manufacturers define and develop the design and installations in alignment with new or retrofit facilities. Experienced in GMP systems/utilities and capital expansions, supporting CMO and CDMO clients.
• 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 development GMP 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 improvement Equipment or system based approach Active event investigations would be summarized with status Identify appropriate corrective action plan(s) to match event(s) Root cause analysis investigation Critical versus non critical instrumentation calibration intervals Out of tolerance response review Risk based assessment of instrumentation and controls Review 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 attempts Guideline documents and templates to complement validated procedures and protocols Initial work may be performed in Word and Excel Later 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.