An ICVS Sr. Specialist must have an extensive knowledge of installation, operational and performance qualifications where necessary. Possess extensive experience with planned maintenance, calibration and validations to avoid expensive shutdowns and unplanned maintenance when necessary. Must have a maintenance background that involves some computerized system and some automation used the laboratory areas with Windows, Word, Excel and other software programs. The assurance of higher level specialists (electro-mechanical) under time and pressure to complete the job is necessary. The senior specialist will interface with the group leader and specialists to complete assignments needed with expertise of the ICVS group. Must be able to perform the responsibilities as the ICVS Senior Specialists/Specialists. Give technical instructions as per manager or group leader requests for maintenance efforts in the aseptic and non-aseptic areas in both aseptic processing departments. Able to perform and maintain routine calibration preventive maintenance task for new and existing equipment and instrumentation such as HPLCs, GCs, LCMSMSs, and CEs. Able to verify validation and qualification documentation for all new and existing analytical instrumentation and equipment complies with and as set to SOPs. Capable to review and submit of completed work order reviews, validation reports and qualification documentation. Able to review and revise maintenance, calibration procedures and methods where needed. Able to diagnose equipment, system and facility breakdowns with effective solutions. Able to provide diagnostic troubleshooting assistance to specialists at site testing, commissioning and validation for HPLCs, GCs, Stability Chambers and Freezers. Ensure that work conforms to all applicable codes and regulations such as OSHA, NEC and cGMPs. Follow safe practices and comply with all safety regulations.


Requires a B. S. degree in Electrical, Electronic, Mechanical, and Related Engineering with courses in Engineering Sciences or Validation Technology or equivalent. A minimum of 4-8+ years of industrial experience in the metrology, calibration, instrumentation or utilities systems needed, including specific exposure to food or beverage, pharmaceutical or biotechnology environments.