About this opportunity
MMR Consulting lists this BIOPHARMACEUTICAL – CQV Manager/PM opportunity in seattle, Washington. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Previous Pharmaceutical/Biotech experience is mandatory for this role.
Relocation packages or travel packages are available for this role.
The work will require working out of client's facilities, in Portland, Oregon.
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 candidates should possess leadership skills to lead teams of intermediate and junior engineers.
This role is to Lead the CQV activities for 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, troubleshooting and/or process improvements of the filling/packaging equipment systems. The ideal candidates 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.
Responsibilities
Lead or participate in design or operationsof packaging pharmaceutical products in their final forms and containers by fill/finish and packaging like, vials, syringes and other delivery systems.
Lead or support project execution from feasibility through project completion/handover.
Develop and manage CQV strategies, project plans, schedules, budgets, and resource allocation.
Communicate effectively with senior leadership and site-level teams.
Work with production and packaging groups to create User Requirements Specifications (URS) for ongoing operations or new projects
Collaborate 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 failures
Assess current packaging operations for troubleshooting, efficiencies and continuous improvement opportunities
Spearhead innovations in packaging technologies to support existing client needs
Perform reliability studies on packaging equipment
Perform optimization studies for the optimal use of packaging equipment systems for use in campaigns
Support documentation and/or execution of FAT/SAT/Commissioning, Qualification of packaging systems
Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, provide updates to higher management
Other 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 phases
Qualifications
College/Bachelors’ Degree or Diploma in Engineering discipline, preferable Mechanical
8+ years in GxP environment typically for design or operation of pharmaceutical packaging operations, including sterile/aseptic manufacturing
Previous experience in the pharmaceutical/biotech industry, with knowledge of requirements for a GMP operations
Possess leadership skills and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity
Ability to handle multiple projects and work in a fast-paced environment.
Ability to lift 50 pounds
Travel and/or off-hours work may be required on occasion
A part of our recruitment process, we may use technology-assisted tools, including AI-enabled systems, to support application review and candidate evaluation. Hiring decisions are made with human oversight and consideration.
Equal Employment Opportunity and Reasonable Accommodations
MMR 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.
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Worksite address
seattle, WA, 98127, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.