Calibration Technician

Job Description

Duties and 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.
• 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.
• 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.
• Supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions.

Regulatory Responsibilities:

• Maintains all required Corporate, Facilities and EHS training as required.
• Adheres to all safety procedures and hazard communication.
• May be called upon to act as SME in both internal and regulatory audits.

Education and Experience:

• High school Diploma or Associates, or Bachelor’s degree.
• 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.

Knowledge, Skills and Abilities:

• 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.

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.

Travel Requirements:

• Local travel is required for this position to support multiple sites.

Additional Job Requirements:

• Position Handles Hazardous Materials.