Calibration Technician

Title : Calibration Technician

Location : On-Site Warren NJ.

Duration : 12 months

PURPOSE AND SCOPE OF POSITION:

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.

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.

DUTIES AND RESPONSIBILITIES

Operational Activities

• 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.

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

• Supports multiple sites within Warren and Summit.

• 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 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.)

• 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.

• Adheres to all safety procedures and hazard communication.

4. 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.

5. 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.