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BIOPHARMACEUTICAL – Senior CQV Engineer

MMR Consulting
Seattle, USA
Senior · 8+ years experience
Onsite
Discovered Today

Full Job Posting

Responsibilities

  • Lead 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 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 cGMP 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
  • As 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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