Calibration Technician – Pharma (Onsite- Warren, NJ)

We are seeking a Calibration Technician for a global pharmaceutical company. The focus of the role is to support the successful operation of laboratory and clinical manufacturing operations at client home site through interaction with internal team members and internal customers, and external service providers

This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role in Warren, NJ.

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 updates CMMS documentation as required.
• Prepares reports and keeps records on calibration inspection, testing, and repairs.
• Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°C / -80°C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas).
• 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.
• 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 the site CMMS system.
• Adheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards.
• 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.)
• 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. Perform NCR’s investigations.
• Regulatory Responsibilities- Maintains all required Corporate, Facilities, and EHS training as required.
  
  

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.)
• Experience in executing 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).
• 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.
• 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.
• Maintenance coordination / planning experience preferred. Experience working in a clinical environment preferred.
• High school Diploma or Associates, or Bachelor's degree.
  
  

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Calibration Technician – 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: $25/hr - $28.48/hr