BIOPHARMACEUTICAL - Filling/Finish CQV Lead

BIOPHARMACEUTICAL - Filling/Finish CQV LeadPrevious 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 Consulting has offices in Canada, USA, and Australia.This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems, and facilities. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.This role is for to work on the filling and packaging operations within a sterile / aseptic pharmaceutical manufacturing environment. Tasks may include all or in part, design / re-design, installation, start-up / commissioning, qualification as well as operation support for analysis, trouble shooting and / or process improvements of the filling / packaging equipment systems. The ideal candidate should possess technical as well as leadership skills to independently perform or manage resources and activities related to the filling and packaging operations.The work will require working out of client's facilities, which are in Portland, Oregon.ResponsibilitiesLead or participate in design or operations of packaging pharmaceutical products into their final forms and containers by fill / finish and packaging like, vials, syringes and other delivery systems.Work with production and packaging groups to create User Requirements Specifications (URS) for ongoing operations or new projectsCollaborate with vendors for packaging machinery, equipment systems, automation controls, materials and consumables, to create Design Specifications (DS) and Functional Specifications (FS) to implement solutions for reducing contamination risks & process failuresAssess current packaging operations for troubleshooting, efficiencies and continuous improvement opportunitiesSpearhead innovations in packaging technologies to support existing client needsPerform reliability studies on packaging equipmentPerform optimization studies for the optimal use of packaging equipment systems for use in campaignsSupport documentation and/or execution of FAT / SAT / Commissioning, Qualification of packaging systemsCoordinate meetings with cross-functional departments to drive project progress, facilitate decisions, provide updates to higher managementOther duties as assigned by client, and / or MMR, based on workload and project requirements.Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phasesQualificationsCollege / Bachelors' Degree or Diploma in Engineering discipline, preferable Mechanical6+ years in GxP environment typically for design or operation of pharmaceutical packaging operations, including sterile / aseptic manufacturingPrevious experience in the pharmaceutical / biotech industry, with knowledge of requirements for a cGMP operationsPossess leadership skills and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexityAbility to handle multiple projects and work in a fast-paced environment.Ability to lift 50 poundsTravel and / or off-hours work may be required on occasionCompensation: 80,000$ -110,000$ based on industry experience.Equal Employment Opportunity and Reasonable AccommodationsMMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.