Senior Process Engineer

Senior Process Engineer

Requirements

• Previous Pharmaceutical/Biotech experience is mandatory for this role
• 10+ years of pharma process engineering experience
• At least 6 years of bioprocess engineering experience (upstream or downstream)
• Knowledge of GMP requirements for working in pharma/biotech facilities
• Excellent written and spoken English is required including the preparation of technical documents in English
• Experience in leading teams
• Experience with, and knowledge of some of the typical Biotechnology processes & peripheral systems is required; Upstream Biotech Processes (Fermentation, Bioreactors, Centrifugation, Thawing), Downstream / Purification Biotech Processes (chromatography, TFF, DF, NF-MF), Fill & Finish equipment, Media Preparation, CIP/SIP systems, Buffer Preparation, clean utilities (PW, WFI, CS, PS)
• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity
• Possess mentorship skills, to coach and develop junior and intermediate employees
• Engineering degree, preferably in Chemical, Biochemical, Mechanical Engineering or a related discipline

Responsibilities

• Provide technical guidance into the design, project management, commissioning and start-up of equipment and facilities, for upgrades, renovations and expansions of client facilities and processes.
• Support project execution from Feasibility through to project completion/handover, including all project stages such as: Feasibility, Concept Design, Basic Design, Detailed Design, Procurement, Construction, Project Monitoring/Governance, Commissioning & Qualification
• Prepare/perform/review process engineering drawings, calculations, whether as part of engineering design or as part of verification of calculations of vendors/client/other consultants, or Junior Engineers at MMR Consulting. Drawings may include PFDs, P&IDs as well as others. Calculations may include heat exchanger, pump, piping, control valve sizing, heat and mass balances, as well as other engineered calculations.
• Prepare/review technical specifications and data sheets for various equipment, instrumentation, and systems (such as vessel data sheets, etc).
• Review technical documentation such as SDS/HDS, layouts, manuals, datasheets.
• Manage other engineering design firms, equipment vendors, construction firms, and internal/external stakeholders as required to execute projects.
• Integrate safety into the design and execution of all projects (HAZOP reviews, PHSRs, design reviews with EHS representatives).
• Prepare/review User Requirements Specifications (URS)
• Provide input into Commissioning (FAT, SAT) and Qualification Protocols (IQOQ), as well as support execution of Commissioning & Qualification.
• Prepare/review automation sequences, as required for Process Automation, such as Functional Specifications, Valve & Alarm Matrices.
• Coordination with other engineering disciplines and other cross-functional departments (automation engineering, facilities engineering, process engineering, validation, project management, operations, quality, safety).
• Facilitate project management tools throughout the execution of projects, such as procurement tracking, vendor management, meeting minutes / action lists, risk register log, schedule updates, project updates.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Travel may be occasionally required for meetings with the client and equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Visit construction and installation sites.
• Supervise contractors during critical installations of process equipment and associated utilities.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.

Preferred Qualifications

• Basic knowledge of AutoCAD is an asset