BIOPHARMACEUTICAL – CQV Manager/PM

MMR Consulting; San Francisco (CA); On-site; USD 140,000 - 180,000; Full time

Job summary

MMR Consulting is hiring for a CQV lead role focused on filling and packaging operations in a sterile/aseptic pharmaceutical manufacturing environment. The position requires leading design, installation, start-up, and qualification activities, with responsibility for schedules, budgets, and cross-functional coordination.

The candidate should have 8+ years in GxP pharmaceutical packaging, strong leadership, and the ability to manage multiple projects in a fast-paced setting, with travel and

Qualifications

• 8+ years in GxP environment for design or operation of pharmaceutical packaging operations, including sterile/aseptic manufacturing.
• Experience in pharmaceutical/biotech industry with GMP operations.
• Leadership skills to lead projects with multiple stakeholders and departments.
• Ability to handle multiple projects in a fast-paced environment.
• Ability to lift 50 pounds.
• Travel and/or off-hours work may be required.

Responsibilities

• Lead or participate in design or operation of packaging pharmaceutical products in final forms and containers by fill/finish and packaging like vials, syringes, etc.
• Lead or support project execution from feasibility through project completion/handover.
• Develop and manage CQV strategies, plans, schedules, budgets, and resources.
• Communicate with senior leadership and site-level teams.
• Work with production and packaging groups to create URS for ongoing operations or new projects.
• Collaborate with vendors for packaging machinery, equipment systems, to create DS/FS for solutions reducing contamination risks & process failures
• Assess current packaging operations for troubleshooting, efficiencies and improvements
• Spearhead packaging tech innovations to support client needs
• Perform reliability studies on packaging equipment
• Perform optimization studies for packaging equipment use in campaigns
• Support FAT/SAT/ commissioning, qualification of packaging systems
• Coordinate meetings with cross-functional departments to drive progress
• Other duties as assigned by client and/or MMR
• Work may require shutdowns or extended hours during installation and validation phases

Skills

CQV leadership

GxP

Project management

Packaging operations

Education

Bachelor's in Engineering

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.