AbbVie Pharmacyclics Senior Calibration Technician in Sunnyvale, California

Senior Calibration Technician

Location: Sunnyvale, CA

# of Openings: 1

Description

General Position Summary

Pharmacyclics is adding to its Facilities team a Sr. Calibration Technician which will be responsible for performing calibration activities at the Sunnyvale site.

The position will review and update company guidelines, procedures. revise calibration schedules, update task lists, print monthly reports, track calibration requests; and uploads data and supporting documents to the CMMS maintenance software.

The calibration tech is expected to take a proactive role in supporting the Team and in providing customer support and is expected to build a high level of trust with customers, and QA personnel. This trust is developed through consistently demonstrating honesty, integrity, pride, accountability, teamwork, and commitment.

In addition the Sr. Calibration Tech is expected to identify and execute tasks that enhance the ability of Pharmacyclics to provide an added value service for the site and provide guidance and direction on technical issues, as well as assist in providing innovative, creative, effective, and long-term solutions.

Key Accountabilities/Core Job Responsibilities

Responsibilities:

  • Responsible for proper handling of equipment, and devices, including testing standards and equipment.

  • Completes calibrations, qualifications, and PMs with accurate and timely GxP documentation, following Pharmacyclics policies and procedures

  • Provides guidance, direction and effective solutions to customers as the Pharmacyclics technical resource.

  • Thorough understanding and application of instrument, equipment, and loop calibrations of various parameters for equipment, utilities, and laboratory environments.

  • Familiarity with Liquid Automation I Robotics I HTS, such as liquid handlers, plate stackers, plate readers, and plate washers, and other general laboratory equipment.

  • Thorough understanding of Traceability, Substitution of Standards, and Test Accuracy and Uncertainty Ratios as part of ISO 17025.

  • Thorough understanding and troubleshooting capability with incubators, centrifuges, balances, refrigerators and freezers, stability chambers, chromatography (HPLC or GC), spectrophotometers, microscopes and other general laboratory equipment as needed.

  • Knowledge of test equipment and capabilities such as tolerance requirements and 4:1 TAR.

  • Exceptional Computer Maintenance Management Systems (CMMS) skills.

  • Thorough understanding and application of GxPs and Life Science industry regulations.

  • Strong applied and working knowledge of FDA; GMP; GLP; compliance and NIST traceability

  • Other tasks as assigned.

Minimum Education

  • Requires a high school diploma

  • 4-year degree in Life Sciences, Engineering, Electronics, other related technical field or equivalent training

  • 4-years of applicable (Metrology, Instrumentation, Calibration) experience or the equivalent combination of education and experience.

  • Actively involved with an external professional organization (ISPE, ASQ, PDA, etc.). External certification preferred (ISA, ASQ, etc.).

KNOWLEDGE AND SKILLS:

  • Solid understanding of GMP utility systems and manufacturing process equipment.

  • Strong working knowledge of GMP compliance requirements related to maintenance operations.

  • Computer proficiency on CAD, Word, Excel, Power Point, Outlook, and Microsoft Project preferred.

  • Previous experience with CMMS (Computerized Maintenance Management System) and BMS (Building Automation Systems) is a plus.

  • Will have advanced understanding of mechanical theory and application to building systems in a Biotech environment.

  • Must have a high degree of problem solving and decision making skills.

  • Must be professional and ethical in all activities and relations.

  • Excellent team-oriented interpersonal communication skills.

  • Proven ability to manage multiple tasks.

  • Excellent time management, scheduling, organizational skills, and attention to detail.

  • Must be analytical, flexible, innovative, and self-motivated.

PHYSICAL DEMANDS:

  • Some locations contain exposure to noise, chemicals, biohazards, odors, dirt and dust, humidity, hot, and cold temperatures, heights, which require continuous awareness of safe working procedures and policies.

  • Walking, climbing ladders and lifting to 50 pounds required. The noise level in the work environment is low to moderate.

  • The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled