BIOPHARMACEUTICAL – Filling/Finish CQV Lead

MMR Consulting•Portland, OR

3d•$80,000 - $110,000•Onsite

About The Position

This role is for a BIOPHARMACEUTICAL – Filling/Finish CQV Lead with MMR Consulting, an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. The candidate will join a growing team and work with engineers on the design, commissioning & qualification, start-up, and project management of various processes, systems, and facilities. The position focuses on filling and packaging operations within a sterile/aseptic pharmaceutical manufacturing environment. Tasks include design/re-design, installation, start-up/commissioning, qualification, and operational support for analysis, troubleshooting, and process improvements of filling/packaging equipment systems. The ideal candidate will possess technical and leadership skills to independently perform or manage resources and activities related to these operations. The work will be performed at client facilities in Portland, Oregon.

Requirements

Previous Pharmaceutical/Biotech experience is mandatory.
College / Bachelors’ Degree or Diploma in Engineering discipline, preferable Mechanical.
6+ 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.

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.