BIOPHARMACEUTICAL – CQV Manager/PM

MMR Consulting; Seattle (WA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Relocation assistance

Travel opportunities

Job summary

MMR Consulting is seeking a CQV Lead to drive commissioning, qualification, and start-up activities for sterile packaging lines at client facilities in Portland. You will define CQV strategies and manage cross-functional teams to ensure compliant, on-time project delivery.

The ideal candidate will bring 8+ years in GMP-enabled packaging environments, strong leadership, and hands-on experience with design, installation, and validation of packaging systems. Travel to client sites may be required.

Qualifications

• 8+ years in GxP environment for design or operation of pharmaceutical packaging operations, including sterile/aseptic manufacturing.
• Previous experience in the pharmaceutical/biotech industry, with knowledge of GMP requirements.
• Possess leadership skills and be able to lead projects with multiple stakeholders.

Responsibilities

• Lead or participate in design or operation of packaging pharmaceutical products in final forms and containers by fill/finish.
• Lead or support project execution from feasibility through project completion/handover.
• Develop and manage CQV strategies, project plans, schedules, budgets, and resource allocation.
• Coordinate meetings with cross-functional departments to drive project progress.

Skills

CQV leadership

GxP

Project management

Packaging operations

Sterile aseptic

Mechanical engineering

Education

Bachelor's degree in Engineering

Tools

FAT

SAT

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.