Job Description
Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.
What You Will Achieve
Working with Pfizer's dynamic engineering team, you will play a critical part in managing the maintenance and reliability engineering activities involving the redesign, maintenance, and repair of utilities systems, buildings, and production/non-production equipment.
You are recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will arrive at decisions on which methods and procedures are the best fit for different work situations.
You will train others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to our patients.
How You Will Achieve It
Performs calibrations in compliance with site policies and procedure and assuring traceability to the National Institute of Standards and Technology (N.I.S.T.).
Perform preventive and predictive maintenance.
Installs, specify, and calibrated process instrumentation and laboratory devices.
Responsible to troubleshooting and repair Instrumentation, monitor and address alarms (i.e. QBMS/BMS) of Automation system.
Participate in safety training programs.
Read and follow equipment schematics, logic diagrams and engineering drawings.
Use calibration equipment/tools in a safe manner.
Make recommendations regarding improved system performance.
Follow all SOP and (Current) Good Manufacturing Practices (part of GxP) requirements.
ROLE SUMMARY
This position maintains all Automation, Manufacturing, Packaging/Inspection, and Utility systems/equipment with a focus on maintenance, repair and calibration of all site instrumentation to ensure operation as specified and in compliance with cGMP and the National Institute of Standards and Technology (N.I.S.T.) requirements.
This position will serve as a SME in areas of engineering to include process design, instrumentation selection, documentation, calibration, testing and problem-solving methodology, etc.
Responsible to troubleshooting, diagnostics, disassembly, assembly, repair, identifying and replacing parts and calibration of the site instrumentation in a cost-effective manner.
ROLE RESPONSIBILITIES
Preventive Maintenance Responsibilities:
Performs preventive and predictive maintenance of instrumentation, following the established guidelines for the CMMS system, operational procedures, site and manufacturer recommended maintenance practices.
Performs calibrations, assuring traceability to the National Institute of Standards and Technology (N.I.S.T.) on instruments and laboratory equipment located throughout the site.
Reports opportunities (i.e., out of tolerance) identified during Preventive Maintenance and Calibration execution.
Installs, repairs, replaces, adjusts process control instrumentation, weighing equipment, and laboratory devices.
Provides recommendations for Preventive Maintenance and Calibration task improvements.
Troubleshoots, and maintains sensors, wiring, and devices that support the Automation systems (Qualified Building Management System, Building Management System, SCADA, Data Historian, etc.).
Follow the weekly maintenance plan and alerts when there might be a risk of not complying with the schedule.
Generates corrective work order to report and coordinate repairs for task out of the scope of the Preventive Maintenance.
Installs, repairs, inspects, test, replace and maintains site instrumentation.
Equipment Troubleshooting Responsibilities:
Installs, inspects, troubleshoots, repairs, and maintains `instrumentation of all Automation, Manufacturing, Packaging, Utilities equipment.
Perform calibration, preventive and corrective maintenance activities.
Required to read and understand drawings and P&IDs utilizing this knowledge for the installation/repair of new and existing equipment/instrumentation.
Develop solutions to routine problems following established Pfizer policies and procedures.
Utilizes tools, equipment, ladders, lifts, etc., in safe manner per site EHS procedures.
Projects Responsibilities:
- Provides support for Capital projects which includes but not limited to instrumentation installation/calibration, commissioning, qualification, inspection, drawing verification, measurements and/or functional testing.
Documentation Responsibilities:
Follows Good Documentation Practices per compliance requirements (i.e., 21 CFR Part 11, Data Integrity).
Completes documentation required for calibration, maintenance work orders and logbooks.
Prepare/Update Calibration Job Aids/Procedures for new Instrumentation.
Generate, review (as SME) and update required Calibration documentation (i.e., instrument form).
Responsible/assist during investigation related to site instrumentation.
Training, SOP's and GMP Responsibilities:
Reads and follows SOPs, Job Aids, PMs, work orders and other required documents and procedures.
Must be able to complete sterile garb training and work aseptically in manufacturing areas.
Complete trainings in PLS and assists as a Calibration SME in trainings for other colleagues as required.
Recommends changes to Maintenance tasks and/or SOP's.
EHS Responsibilities:
Follows EHS procedures, recommended practices, job safety analysis and safe work permit.
Report any abnormal situation that can impact environment, health and or safety of the colleague.
Communication Responsibilities:
- Maintain an open and effective channel of communication with direct supervisor, operational areas and functional areas.
General / Other Responsibilities:
Assists other trades when necessary (troubleshooting, repairs, etc.) and or perform other duties as instructed.
Ability to learn how to operate Power trucks / Power lift and elevated platforms.
Housekeeping - Responsible for keeping assigned areas, as well as general areas clean and organized.
Escort contractors.
Attend meetings as requested.
Coordinate (i.e. coordinate/schedule, issue purchase order) vendor calibrations.
May perform any other Engineering or Maintenance duty as requested by management.
BASIC QUALIFICATIONS
Applicant must have a high school diploma and/or general education degree (GED).
Associate degree or Technical Trade school diploma in Electronics technology, Metrology, Instrumentation, Electrical Engineering or equivalent.
5+ of industrial GMP Calibration Maintenance experience.
Demonstrated aptitude in electrical and instrumentation skills.
Knowledge of industry practices and standards.
Knowledge of basic mathematics.
Well-developed time management and problem-solving skills.
Excellent communication skills and strong work ethic.
PREFERRED QUALIFICATIONS
OEM trained in industrial instrumentation and calibration systems (i.e., Fluke, Siemens, Ashcroft, GE, Emerson).
Experience with laboratory analytical instrumentation, computer technology, automation equipment and PLC technology.
OEM trained and certified in industrial electrical systems (NFPA-70E).
GMP Maintenance experience in a pharmaceutical manufacturing
PHYSICAL/MENTAL REQUIREMENTS
This position is in a Penicillin Facility. The
