Qualification and Validation Expert | MIVADO GlobalPerformance · Teeming.ai
MIVADO GlobalPerformance
Mivado GlobalPerformance (MGP) is a consulting, advice, and training firm founded in 2004. They offer a wide range of expertise in Quality, Compliance, Regulatory Affairs, Project Management, Good…
Mivado GlobalPerformance (MGP) is a consulting, advice, and training firm founded in 2004. They offer a wide range of expertise in Quality, Compliance, Regulatory Affairs, Project Management, Good…
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Company Description
Mivado GlobalPerformance Inc. (MIVADO GP) is a global consulting firm specializing in providing expert advice, services, and training to public and private organizations. Known for its expertise in areas such as Artificial Intelligence, Digital Transformation, Quality Management, Validation, GMP Compliance, and Continuous Improvement, MIVADO GP is a leader in the life sciences market. We are dedicated to delivering tailored performance solutions that integrate optimization, innovation, and quality to meet partner needs. With a commitment to exceptional customer support and a comprehensive service portfolio, MIVADO GP drives value and excellence in various industries. Headquartered in Quebec, Canada, MIVADO partners with clients worldwide to achieve strategic operational success.
Role Description
Mivado GlobalPerformance is looking for a Specialist in process/chemical engineering to join our Industrial design team to support the engineering, design, commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in various consumer goods/food/beverage/chemical markets. In this role, you will lead conceptual and detailed design efforts on key projects, train and mentor other junior engineers, and resolve design problems. We strongly encourage chemical engineers/process engineers with any type of bioprocessing/biomanufacturing/industrial large-scale fermentation experience to apply.
Responsibilities
Qualifications
Ability to lift 50 lbs.
Excellent written and spoken English is required including the preparation of technical documents in English
Years of experience: 3+ years of process engineering experience in pharma/biotech or in core biopharmaceutical unit operations (upstream or downstream).
Knowledge of GMP requirements for working in pharma/biotech facilities, with a Basic understanding of SOPs, Validation, and Change Controls.
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.
Prepare/perform/review process engineering drawings, and calculations, whether as part of engineering design or as part of verification of calculations of vendors/clients/other consultants. 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 engineering 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, and 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 required for meetings with, clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
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.
Basic knowledge of AutoCAD is an asset.
Engineering degree, preferably in Chemical, Biochemical, Mechanical Engineering or a related discipline.
