Pharmaceutical Bioprocess Engineer

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).

**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 engineering calculations.
- Prepare/review technical specifications and data sheets for various equipment, instrumentation, and systems (such as vessel data sheets, etc).
- Perform change control and deviation management for processes/ process equipment via Trackwise.
- 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 required for meetings with, clients, 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.
- 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
- 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.

**Qualifications**
- Years of experience: 5+ years of process engineering experience in pharma/biotech, with at least 3 years of process engineering experience 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, Change Controls.
- 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)
- Experience in performing change control and deviation management for processes/ process equipment via Trackwise.
- Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
- Possess mentorship sk