Lead, Instrumentation & Calibration

LeadInstrumentation and Calibration (I&C)

AsLeadInstrumentation and Calibration,you’lloversee departmental activitiesin regard tothe planning and scheduling of all routine and non-routinecalibrationevents and any related areas of responsibility in order to maintain a GMP facility.

Responsibilities:

• As Business Process Owner forInstrumentationand Calibration activities – proactivelyutilizeLean to drive continuous improvement across process and procedures, whereappropriate utilizingdigital technology with the aim of reducing waste and increasing benefit.

• Development and implementation of the site’sInstrumentationandCalibrationstrategy to ensure continued compliance with regulatory requirementsand industry standards(cGMP, GAMP, ICH,ISPE).

• Proactiveday-to-daymanagement and performance development of theinstrumentationandcalibrationteams and relevant external service providers to ensure alignment to schedule, efficient delivery of operations and processoptimization.

• Lead troubleshooting and repair efforts to return equipment to normaloperationsuch asprocess control systems, electromechanical,pneumaticscontrolsdevices for manufacturing applications and utility supportsystem.

• Assistmanufacturing and facilities personnel in troubleshooting and diagnostic analysis on process and utilityequipment.   

• Capacity to function as anadministratorfor theCMMS for the site, overseeing all assets lifecycle records.

• Track KPI for work order completion and non-conformance trending, seeking resolutionwith assets ownersin accordancewiththeplanesschedule and business priority.

• Continuously evaluate instrumentationand calibrationpracticestoeliminatenonproductive activities and implementcosteffectivesprocesses.

• Manage the acquisitionand handling of standards,special tools, calibration equipment, sparepartsand servicelevels ofagreements tosupport thesite'soperation.

• Write, revise and review Standard Operating Procedures, adhering to schedules and interfacing in a constructive manner with all vendors, contractors, associates,peers,and managers.

Requirements:

• Minimum of a High school diploma.  

• Minimum of7yearsindustrial maintenance experience in a GMP facility to include both facility and process related equipment and its controls oran equivalent.  

• Minimum of 3years in a lead or supervisory capacity. 

• Extensive knowledge in specialized functions and a comprehensive acquaintance with instrumentation and calibration principles and practices.

• Strong organizational andleadershipskills.

• Extensive knowledge of cGMP standards, in particular manufacturing, laboratory and requirements for computer systems (GAMP) and data integrity.

• Excellent written and verbal communication skills

The annual base pay for this position ranges from $89,874.40 - $134,811.60. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.