Pfizer Sr. Manufacturing Process Engineer in St. Louis, Missouri
The Senior Manufacturing Process Engineer is a key technical role responsible for ensuring consistently high performance of manufacturing equipment and processes working in a cGMP environment. This individual contributor role requires strong focus on driving performance and quality into the Packaging and Inspection (P&I) production processes, implementation of best practices, and continuous improvement. The incumbent will provide focused process and equipment performance with direct technical expertise to ensure high quality and efficient inspection, assembly and packaging of auto injector products. As technical lead, the Sr. Process Engineer partners with Management, Supervision and Shop floor colleagues to identify and implement innovative solutions. Additional duties including project management, six sigma methods, and training are required.
Technical Experience with proven direct hands on ability within the following disciplines is required:
Automated Inspection Equipment - (Inspection Tool / Recipe creation and modification)
Direct experience with Manufacturing, Automation, Robotics, Automated Vision Systems, Facilities and Utilities
Direct experience with Assembly, Labeling and Packaging Equipment and Manufacturing Processes.
Direct experience with programming automated equipment / systems.
Assigned Technical Leader and owner of inspection and packaging manufacturing equipment and process systems.
Subject Matter Expert for Automated Inspection, Assembly and Packaging equipment.
Work closely with Vendors to identify new equipment and new technologies to automate P&I operations.
Production Lead for new equipment FAT (Factory Acceptance Testing) and SAT (Site Acceptance testing).
Production Lead for developing new manufacturing equipment URS (User Specifications) documents.
Serves as Production Operational Excellence support lead, M-1 facilitator or RFT project leader to drive continuous improvement by reducing RIDS, improve supply performance, maximize capacity and encouraging innovation.
Ensures compliance with Pfizer Quality Standards requirements.
Investigates deviations that occur on the manufacturing floor. Performs root-cause analysis and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering/maintenance, quality, validation, environmental health and safety. This will include writing investigations as the responsible person.
Develop and implement, and permanently resolve problems through root cause analysis.
Ownership and completion of assigned CAPA Commitments.
Partner with Quality, OpEx, Continuous Improvement and other internal experts to develop quality investigations, assign root cause, and identify/implement CAPA solutions.
Project Manager for implementation of equipment /process changes related to P&I manufacturing operations.
As an individual contributor, represent P&I operations on assigned project teams to ensure completion of key projects initiatives.
Act as internal process training resource for both Management and P&I shop floor team as needed.
Identify and implement cost savings initiatives, specifically quality and efficiency improvements.
Maintain product and company reputation by complying with government regulations; and champions manufacturing safety initiatives.
Lead technical improvement projects aimed at "zero defects", improved equipment reliability, and maximized utilization.
Anticipate potential process-related problems, risks, and technical conflicts and develop necessary contingency plans that optimize business continuity.
Foresees potential issues and roadblocks and develops contingency plans.
Ensure work activities are conducted in strict accordance with safety guidelines and processing standards, such as FDA's current Good Manufacturing Practices (cGMPs) and SOPs.
- Bachelor's degree (or higher) in Chemical Engineering, Mechanical Engineering, Electrical Engineering or a Science-related field.
5-10 years of direct experience with Manufacturing Automation, Robotics, Automated Vision Systems.
Direct experience and Knowledge of electro-mechanical principles and automated machine process controls.
Demonstrated ability to develop equipment requirements (URS) and manage project tasks to install and implement automated manufacturing equipment and related new processes.
Ability to clearly present technical information and effectively communicate within all levels of the organization.
Demonstrated ability to contribute to and lead project teams.
Demonstrated ability to participate in Regulatory Inspections as a Subject Matter Expert.
Clear thinker: simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information and communicating priorities clearly and concisely.
Previous manufacturing experience preferred.
Technical Skills Requirements:
Direct Technical Experience with Automated Inspection Equipment, Assembly, Labeling and Packaging Equipment and Processes.
Direct Technical Experience with Automated Manufacturing systems, Robotics, Facilities and Utilities.
Must be able to apply solid reasoning skills to an investigation and to project planning.
Must be self-motivated and flexible to learn and respond to changing responsibilities and priorities.
Demonstrated commitment to values-based leadership and achieving objectives in a manner that is consistent with Pfizer Leader Behaviors.
Demonstrated ability to interact effectively with all levels of the organization.
Strong oral and written communication skills required.
Possess flexibility to respond to constantly changing conditions and priorities.
Six-Sigma training and project management experience is highly preferred.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment.
The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.
Other Job Details:
Last Date to Apply for Job: March 26, 2019
Additional Location Information: St Louis, MO (Westport)
Eligible for Relocation Package
Eligible for Employee Referral Bonus
N (Other) (United States of America)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.