Equipment Engineer- Pharma (Onsite- Warren, NJ)

Equipment Engineer- Pharma (Onsite- Warren, NJ)

We are seeking an Equipment Engineer for a global pharmaceutical client. The focus of the role is to execute equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System.

This is a 40-hour per week, 12-month contract (extensions possible), 100% onsite role at client's office, in Warren, NJ. Work Schedule : Mon-Fri(normal business hours)

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Responsibilities :

Executes equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System.

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 multiple sites within Warren.

Supports clinical manufacturing on-call equipment troubleshooting activities during weekends as required

Contacts supplier for quotation on external calibration / PM of the equipment and calibration standards. Initiates, participates, and assists in resolution of quality investigations.

Authors and supports the development, revision, and review of written Standard Operating Procedures (SOP) for calibration, preventive maintenance, and performance verification of instruments / equipment

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.

Ensure low cost of the Laboratory Systems Management (LSM) department (Reducing overtime, implementing innovative ideas)

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.

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.

Inventory Management

Work with Planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed.

Approves Change Request, Asset Inductions, and Work Request.

Approving Calibration and Maintenance forms. Perform NCR's investigations.

Regulatory Responsibilities

Maintains all required Corporate, Facilities and EHS training as required.

Adheres to all safety procedures and hazard communication.

Requirements :

3+ years of experience in FDA-regulated industry

3+ years of experience working directly with laboratory equipment (ex. centrifuges, temperature / humidity meters, balances, freezers, refrigerators etc.)

Maintenance coordination / planning experience preferred.

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. Knowledge of cGMP and good documentation practices.

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.

Required BS in Engineering or Science related discipline preferred.

Please submit your resume to our network at https : / / www.stage4solutions.com / careers / (please apply to the Equipment Engineer- Pharma (Onsite- Warren, NJ) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion / belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation : $40 / hr. - 45. 45 / hr.

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