Senior Calibration Technician

Are you ready to make a meaningful impact in the heart of Research Triangle Park (RTP), North Carolina? We are seeking a Senior Calibration Technician for a full-time, permanent role to join a fast-growing, innovative life sciences company dedicated to improving patient outcomes. This on-site position offers a dynamic and collaborative environment where you'll work with cutting-edge laboratory equipment, ensuring its optimal performance for essential research and development.

As a Senior Calibration Technician, you will play a critical role in maintaining, calibrating, and repairing laboratory instruments, ensuring compliance with regulatory standards while supporting groundbreaking work in the Pharma and Biotech industry. If you have a strong metrology background and a passion for precision, this is your chance to contribute to the forefront of scientific advancement.

The company you'll be working as part of is at the cutting edge of genetic transformation, and dedicated to reshaping lives. They were established in clinical-stage gene therapy more than 20 years ago, and have grown a rich portfolio of therapeutic programs, unmatched AAV manufacturing, and groundbreaking patented technology, their core therapeutic focus is broad, spanning neuromuscular, central nervous system, cardiovascular, and metabolic diseases.

Your role as Senior Calibration Technician

• Plan and execute calibration, maintenance, and repairs on laboratory equipment independently, utilizing the Computerized Maintenance Management System (CMMS).
• Oversee and manage on-site vendors, ensuring they meet all training and compliance standards for equipment servicing.
• Conduct detailed reviews and approvals of calibration and maintenance documentation from external vendors, focusing on good documentation practices.
• Lead investigations related to equipment calibration failures and other technical issues, ensuring swift resolution.
• Assist in the induction of new equipment by developing calibration schedules and requirements in collaboration with equipment owners.
• Research operating specifications of new equipment and develop appropriate calibration standards and acceptance criteria.
• Perform thermal mapping studies for controlled environments to validate and enhance equipment performance.
• Generate and maintain Standard Operating Procedures (SOPs) related to the operation, maintenance, and calibration of lab instrumentation.
• Interface with multidisciplinary teams including Quality Assurance, IT, Facilities, and Engineering to ensure seamless equipment operation.
• Thoroughly document all activities within the CMMS to ensure data integrity and compliance.
• Ensure compliance with industry regulations, including USP, NIST, FDA, GLP, and GMP, during all calibration and mapping activities.

Experience and qualifications for the Senior Calibration Technician role

Essential Qualifications:

• 8-10 years of metrology experience, or a Bachelor's Degree and 5+ years of relevant experience.
• Experience working within the Pharma or Biotech industries.
• Strong understanding of calibration methodology, including loop calibrations and tolerances.
• In-depth knowledge of FDA and GxP regulations, with hands-on experience in GMP and GLP environments.
• Familiarity with CAPA investigations and deviation management.
• Ability to read and interpret technical drawings for instrumentation.
• Proficient in working with laboratory analytical instrumentation and small-scale manufacturing equipment.
• Excellent communication and organizational skills, with the ability to work independently in a fast-paced environment.

Preferred Qualifications:

• Bachelor's Degree in a relevant field.
• Certified Calibration Technician (CCT).
• Experience working in CLIA and R&D laboratory environments.

Ready to take your career to the next level? Apply now for immediate consideration, or reach out directly for more information about similar opportunities within the life sciences sector.