About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
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. The role requires strong focus on driving quality into the Packaging and Inspection (P&I) production processes, implementation of best practices, and continuous improvement. The incumbent will provide focused process ownership and the 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 coordination are required.
Technical Experience with the following disciplines is recommended:
• Automated Inspection Equipment.
• Assembly, Labeling and Packaging Equipment and Processes.
• Knowledge of Automation, Facilities and Utilities
• Assigned technical lead and owner of P&I manufacturing equipment and process systems.
• Subject Matter Expert for Automated Inspection, Assembly and Packaging equipment.
• Serves as Manufacturing Site Operational Excellence 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 PQS 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.
• 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.
• As an individual contributor, represent manufacturing on assigned to project teams to ensure completion of key projects initiatives.
• Act as internal process training resource for both Management and P&I shop floor team.
• 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.
• Knowledge of electro-mechanical principles and automated machine process controls.
• Demonstrated ability to develop equipment requirements and manage project tasks to install and implement 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.
• 5-10 years' experience in pharmaceutical manufacturing and background in manufacturing or quality.
• Previous manufacturing experience preferred.
Technical Skills Requirements:
• Technical Experience with Automated Inspection Equipment, Assembly, Labeling and Packaging Equipment and Processes.
• Knowledge of Automation, 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 the company 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 preferred.
Physical Position Requirements:
• Expected to spend time majority of time on the shop floor, and be trained in the appropriate gowning.
• May require travel to vendors
• Job may also entail occasional weekend /evening work (2nd & 3rd Shift).
• Requires walking, lifting, flexibility to work on production equipment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT:
Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company 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. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment.
This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. •1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. •1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.
A little about us:
Join Pfizer in our mission to find sustainable solutions to the most urgent health care challenges of our time. Your service is needed.