Job Description

Job Title: Calibration Technician

Location: Warren, NJ 07059

100% onsite

Work Schedule: Mon - Fri, Business Hours

Top Skills:

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.

Position Summary

The LSM Calibration Technician supports the successful operation of laboratory and clinical manufacturing operations at their home site through interaction with internal team members and internal customers, and external service providers.

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.

Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°C / -80°C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas).

Documents and populates calibration/maintenance information in WPT (Work Plan Template) or MDT (Measurement Data Template) using CMMS system.

Supports multiple sites within Warren and Summit.

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

Required Competencies:

• 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.

Education and Experience:

• High school Diploma or Associates or Bachelor's degree.

• 3+ years of lab experience preferred in pharma or medical device industry or manufacturing.

WORKING CONDITIONS

Physical / Mental Demands:

• Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25 lbs.

• Ability to sit, stand, walk, and move within workspace for extended periods.

• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.

Environmental Conditions:

• Environment may include working in office, laboratory, or manufacturing area.

• Donning proper gowning and/or PPE such as safety glasses and shoes in an environment with hazardous materials and waste will be required.

• Working safely and effectively when working alone or working with others will be required.

Additional Job Requirements:

Position Handles Hazardous Materials

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