Senior Manager - Technical Services

USE YOUR POWER FOR PURPOSE

At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world.

WHAT YOU WILL ACHIEVE

In this role, you will:

• The Senior Principal Process & Packaging Engineer provides senior technical leadership for Primary Packaging Components, Medical Device Combination Products (MDCPs), and advanced statistical analysis supporting sterile injectable manufacturing. This role leads a team of scientists and engineers responsible for packaging component lifecycle management, device-related investigations and changes, and data-driven defect trending to ensure robust, compliant, and reliable commercial supply.

  The position serves as a site Subject Matter Expert (SME) for primary packaging systems, delivery devices, and statistical process monitoring, and partners cross-functionally with Manufacturing, Quality, Validation, Supply Chain, Procurement, and Global Technical Services to drive continuous improvement, investigation excellence, and regulatory compliance.

KEY RESPONSIBILITIES

People & Technical Leadership

• Lead, coach, and develop a team of scientists and engineers supporting primary packaging components, MDCPs, and process analytics.

• Set technical direction, prioritize work, allocate resources, and manage performance, development, and goal setting.

• Serve as a senior technical mentor and escalation point for complex investigations, deviations, and regulatory-facing issues.

Primary Packaging Components

• Provide technical ownership for primary packaging components (e.g., vials, stoppers, seals, syringes, cartridges) across their lifecycle.

• Serve as SME for:

  • Packaging component qualifications and re-qualifications

  • Supplier Change Notifications (SCNs) and Supplier Corrective Action Requests (SCARs)

  • Packaging-related deviations, investigations, and root cause analyses

• Author, review, and approve:

  • Component and packaging specifications

  • Bills of material

  • Change controls, engineering trials, and technical reports

• Interface directly with component suppliers and represent site capabilities in cross-site and global forums.

• Ensure component designs and specifications are compatible with existing and new manufacturing and packaging equipment.

Medical Device Combination Products (MDCP)

• Provide technical leadership for delivery devices and combination products, including syringes, and related systems.

• Lead and support:

  • Device-related investigations and discrepancy resolution

  • Root cause analysis and CAPA development for device failures

• Manage and assess changes to device components, suppliers, or manufacturing processes to ensure regulatory compliance.

• Support device verification, risk assessments, mitigation strategies, and risk management plans.

• Partner with internal and external manufacturing sites and third-party vendors to implement changes and support commercial supply.

Statistical Analysis & Defect Trending

• Lead statistical trending and monitoring of:

  • Critical Quality Attributes (CQAs)

  • Critical Process Parameters (CPPs)

  • Visual inspection and defect data

• Apply statistical tools to:

  • Identify process variability and emerging trends

  • Support investigation hypotheses and root cause determinations

  • Evaluate effectiveness of CAPAs

• Establish and maintain data-driven approaches to defect reduction, process control, and continuous improvement.

• Communicate statistical findings clearly to technical, quality, and leadership stakeholders.

Continuous Improvement

• Develop experimental protocols, execute studies, analyze data, and author technical reports.

• Participate in start-up of new equipment, components, devices, or processes.

• Identify and implement process, packaging, and device improvements to:

  • Improve yield and reliability

  • Reduce defects and variability

  • Maintain regul