Calibration Technician

LanceSoft Inc

Morrisville, NC

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Calendar Management, Calibration, Communication Skills, Computer Systems, Computerized Maintenance Management System (CMMS), Corporate Policies, Cross-Functional, Documentation, Equipment Maintenance/Repair, Equipment Specification, FDA (Food and Drug Administration), FDA Requirements, Facilities Engineering, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), GxP, High School Diploma, Information Technology & Information Systems, Instrumentation, Laboratory Analysis, Laboratory Equipment, Laboratory Management, Laboratory Operations, Maintenance Services, Manufacturing Equipment, Metrology, Organizational Skills, Performance Tuning/Optimization, Presentation/Verbal Skills, Purchasing/Procurement, Quality Assurance, Realtime Transport Protocol, Regulations, Regulatory Compliance, Regulatory Requirements, Requirements Management, Research & Development (R&D), Standard Operating Procedures (SOP), System Validation, Team Player, Technical Drawing, Technical Leadership, Technical Writing, U.S. National Institute of Standards and Technology (NIST), Vendor/Supplier Management, Writing Skills

LOCATION

Morrisville, NC

POSTED

30+ days ago

The Senior Calibration Technician, reporting to the Manager, Laboratory Operations, will be responsible for independently managing laboratory equipment calibrations, maintenance, and repairs in coordination with external vendors and laboratory staff at our RTP locations. Responsibilities: Independently plans, schedules, and performs maintenance, calibration, and repairs on active equipment utilizing the Computerized Maintenance Management System (CMMS). Oversees and manages onsite vendors to ensure all training and compliance requirements are met for maintenance, calibration, and repairs on laboratory equipment. Reviews and approves equipment calibration and maintenance documentation performed by external vendors with a detailed eye for good documentation practices. Initiates, writes, and assists with investigations related to instrument calibration failures or other instrument related issues. Induction of new equipment including development of calibration requirements and schedules in coordination with equipment owners. Research the operating specifications of new equipment, obtain suitable standards, and establish the calibration acceptance criteria. Conducts thermal mapping studies for controlled environments to validate and optimize equipment performance. Maintains and/or generates SOPs or other controlled documents pertaining to operation, maintenance, and calibration of laboratory instrumentation and equipment. Reviews system documentation, including user requirement documents and specification documents for instrumentation. Interfaces with multi-disciplinary teams regarding laboratory equipment including, lab staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT. Contacts and obtains technical information from vendors or service providers. Thoroughly documents all activities and reviews all data to ensure completeness and accuracy within the CMMS. Adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external. Ensures all calibration and thermal mapping activities comply with relevant industry regulations (e.g., USP, NIST, FDA, GLP, GMP). Minimum Requirements: High School Diploma and 9+ years of metrology experience OR Bachelor’s Degree and 5+ years of metrology experience is required. Experience working in the Pharma/Biotech industry. Understanding of calibration methodology and tolerances. Experience working with loop calibrations. Understanding of FDA and GxP regulations and requirements. Experience working in GMP, GLP environments. Experience investigating and completing CAPAs and deviations. Ability to read and interpret instrument technical drawings. Working knowledge and understanding of laboratory analytical instrumentation and small-scale manufacturing equipment. Ability to work independently in a fast-paced, highly interactive environment with excellent self-organization skills. Excellent verbal and written communication skills. Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team. Preferred Requirements: Bachelor’s Degree in a relevant field Certified Calibration Technician Experience working in CLIA, and R&D laboratory environments

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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