Joulé
Job Title: Equipment Engineer
Location: Warren, NJ
Type: Contract
Compensation: $40 - $45.25 hourly
Contractor Work Model: Onsite
Full Job Description
Executes equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System.
Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°C / -80°C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas).
Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions.
Authors and supports the development, revision, and review of written Standard Operating Procedures (SOP) for calibration, preventive maintenance, and performance verification of instruments/equipment.
Escorts and supervises vendors for calibration, preventative maintenance, performance verification and repair functions as required per current scheduling (CMMS) System.
Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness.
Documents and populates calibration/maintenance information in WPT (Work Plan Template) or MDT (Measurement Data Template) using CMMS system.
Modifies or update CMMS documentation as required.
Prepares reports and keeps records on calibration inspection, testing, and repairs.
Manages and trains the calibration technicians. Directs and assists technicians during the equipment issues and repairs.
Supports clinical manufacturing on-call equipment troubleshooting activities during weekends as required.
Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
Contacts supplier for quotation on external calibration/PM of the equipment and calibration standards.
Initiates, participates, and assists in resolution of quality investigations.
Supports the development, review and approval of calibration and maintenance plans in site CMMS system.
Supports the execution of process improvement studies, as required.
Adheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards.
Performs inventory of the equipment and/or standards in the labs as required.
Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment.
Participates actively in special projects as required.
Ensure low cost of the Laboratory Systems Management (LSM) department (Reducing overtime, implementing innovative ideas).
Plans, justify and implement cost reduction small projects.
Usage of several test equipment and tools (e.g., pressure gauges, temperature, humidity meters, flow meters, particle counters and temperature mapping equipment etc.).
Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions.
Support the development, review and approval of calibration and maintenance plans in site CMMS system.
Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate). In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available.
Qualifications
Knowledge of cGMP and good documentation practices.
Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
Strong problem-solving skills and the ability to work independently.
Excellent interpersonal and communication skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required.
Strong multi-tasking and organizational ability. Ability to effectively manage multiple tasks and activities simultaneously.
Proficiency in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications.
Working knowledge of scheduling software and systems, and inventory management systems, e.g., Blue Mountain RAM and/or Maximo Computerized Maintenance Management System (CMMS) preferred.
Ability to interact effectively with QC, Manufacturing, QA, and Engineering & Facilities groups.
Required BS in Engineering or Science related discipline preferred.
Minimum 3 years of experience in FDA-regulated industry.
Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.).
Maintenance coordination / planning experience preferred.
Experience working in a clinical environment preferred.
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Ref: #558-Scientific
#J-18808-Ljbffr
Location: Warren, NJ
Type: Contract
Compensation: $40 - $45.25 hourly
Contractor Work Model: Onsite
Full Job Description
Executes equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System.
Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°C / -80°C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas).
Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions.
Authors and supports the development, revision, and review of written Standard Operating Procedures (SOP) for calibration, preventive maintenance, and performance verification of instruments/equipment.
Escorts and supervises vendors for calibration, preventative maintenance, performance verification and repair functions as required per current scheduling (CMMS) System.
Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness.
Documents and populates calibration/maintenance information in WPT (Work Plan Template) or MDT (Measurement Data Template) using CMMS system.
Modifies or update CMMS documentation as required.
Prepares reports and keeps records on calibration inspection, testing, and repairs.
Manages and trains the calibration technicians. Directs and assists technicians during the equipment issues and repairs.
Supports clinical manufacturing on-call equipment troubleshooting activities during weekends as required.
Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
Contacts supplier for quotation on external calibration/PM of the equipment and calibration standards.
Initiates, participates, and assists in resolution of quality investigations.
Supports the development, review and approval of calibration and maintenance plans in site CMMS system.
Supports the execution of process improvement studies, as required.
Adheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards.
Performs inventory of the equipment and/or standards in the labs as required.
Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment.
Participates actively in special projects as required.
Ensure low cost of the Laboratory Systems Management (LSM) department (Reducing overtime, implementing innovative ideas).
Plans, justify and implement cost reduction small projects.
Usage of several test equipment and tools (e.g., pressure gauges, temperature, humidity meters, flow meters, particle counters and temperature mapping equipment etc.).
Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions.
Support the development, review and approval of calibration and maintenance plans in site CMMS system.
Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate). In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available.
Qualifications
Knowledge of cGMP and good documentation practices.
Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
Strong problem-solving skills and the ability to work independently.
Excellent interpersonal and communication skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required.
Strong multi-tasking and organizational ability. Ability to effectively manage multiple tasks and activities simultaneously.
Proficiency in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications.
Working knowledge of scheduling software and systems, and inventory management systems, e.g., Blue Mountain RAM and/or Maximo Computerized Maintenance Management System (CMMS) preferred.
Ability to interact effectively with QC, Manufacturing, QA, and Engineering & Facilities groups.
Required BS in Engineering or Science related discipline preferred.
Minimum 3 years of experience in FDA-regulated industry.
Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.).
Maintenance coordination / planning experience preferred.
Experience working in a clinical environment preferred.
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Ref: #558-Scientific
#J-18808-Ljbffr