Job Description

LEAD PROCESS ENGINEER
Previous Pharmaceutical/Biotech experience is mandatory for this role.
MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries. Its services include Engineering, Project Management, and Validation. MMR has offices in Canada, USA, Australia, India and Singapore. This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in the design, project management, commissioning and qualification, of equipment, systems and facilities. This role is based out of Singapore. Some travel to client sites is expected. This role is for Lead Process Engineer to lead the process design work of upstream and downstream bioprocess systems/equipment and single-use technology equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead/mentor junior engineers.
Responsibilities

• Provide technical guidance into the design, project management, commissioning and validation, and start-up of various processes and equipment.
• Perform/review process engineering drawings and 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 data sheets for various equipment, instrumentation, and systems (such as vessel data sheets, etc…).
• Prepare/review risk assessments and HAZOPs.
• Provide technical process engineering guidance to junior and intermediate level engineers.
• Prepare/review automation sequences, as required for Process Automation.
• Coordination with other engineering disciplines and other cross-functional departments (automation engineering, facilities engineering, process engineering, validation, project management, operations, quality, safety).
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, into design reviews and decisions.
• Prepare, review, execute commissioning and validation protocols, and reports, as well as requirements specifications, such as User Requirements Specification (URS).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Experience with, and knowledge of some of the typical Biotechnology processes, and peripheral support systems is required; Single-Use Technologies, Upstream Biotech Processes (Fermentation, Bioreactors, Centrifugation, Thawing), Downstream / Purification Biotech Processes (chromatography, TFF, DF, NF-MF), Fill & Finish equipment, Compounding, Media Preparation, CIP/SIP systems, Buffer Preparation, washing equipment, autoclaves, isolators, clean utilities (PW, WFI, CS, PS)
• The work may require working out of client’s facilities.
• You may be involved with other aspects such as 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.
• As this position requires working on client sites, you will need to comply with the client’s safety rules including mandatory vaccination policies for COVID-19, where applicable
• 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.

• Knowledge of GMP requirements for working in pharma/biotech facilities, with a Basic understanding of SOPs, Validation, Change Controls.
• 12 – 20 years of experience in process design/engineering (biologics USP, DSP and SUT), as well as experience in commissioning, and validation of various process systems.
• 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, Compounding, Media Preparation, CIP/SIP systems, Buffer Preparation, washing equipment, autoclaves, isolators, 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 employees.
• Basic knowledge of AutoCAD is an asset.
• Engineering degree, preferably in Chemical, Biochemical, Mechanical Engineering or a related discipline.
• Travel may be required on occasion.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills.