Validation Engineer

Role Title: Validation Engineer (BioPharma)

Duration: 1 year contract

**Responsibilities **.
- Support project execution from Feasibility through to project completion/handover, including all project stages such as:

- Feasibility
- Concept Design, Basic Design, Detailed Design
- 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).

Manage and coordinate with other engineering design firms, equipment vendors, construction firms, and internal/external stakeholders as required to execute projects.
- 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.
- Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities.
- Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
- Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
- Drive the C&Q of upstream or downstream bioprocess systems.
- Coordination with other engineering disciplines and other cross-functional departments (automation engineering, facilities

**Qualifications**
- Excellent written and spoken English is required including the preparation of technical Documents in English
- Knowledge of GMP requirements for working in pharma/biotech facilities, with a Basic understanding of SOPs, Validation, Change Controls.
- Experience in leading teams.
- Min. Years of experience: 3+ years of bioprocess engineering and C&Q / validation experience (upstream or downstream).
- 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)
- Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
- Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches,
- Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required.
- Experience with qualification or validation of clean utilities and HVAC/ISO clean rooms.
- Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
- 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.
- Basic knowledge of AutoCAD is an asset.
- Engineering degree, preferably in Chemical, Biochemical, Mechanical Engineering or a related discipline.