Lead, Instrumentation & Calibration

AstraZeneca • Rockville, MD

19d

About The Position

As Lead Instrumentation and Calibration, you’ll oversee departmental activities in regard to the planning and scheduling of all routine and non-routine calibration events and any related areas of responsibility in order to maintain a GMP facility.

Requirements

• Minimum of a High school diploma.
• Minimum of 7 years industrial maintenance experience in a GMP facility to include both facility and process related equipment and its controls or an equivalent.
• Minimum of 3 years in a lead or supervisory capacity.
• Extensive knowledge in specialized functions and a comprehensive acquaintance with instrumentation and calibration principles and practices.
• Strong organizational and leadership skills.
• Extensive knowledge of cGMP standards, in particular manufacturing, laboratory and requirements for computer systems (GAMP) and data integrity.
• Excellent written and verbal communication skills

Responsibilities

• As Business Process Owner for Instrumentation and Calibration activities – proactively utilize Lean to drive continuous improvement across process and procedures, where appropriate utilizing digital technology with the aim of reducing waste and increasing benefit.
• Development and implementation of the site’s Instrumentation and Calibration strategy to ensure continued compliance with regulatory requirements and industry standards (cGMP, GAMP, ICH, ISPE).
• Proactive day-to-day management and performance development of the instrumentation and calibration teams and relevant external service providers to ensure alignment to schedule, efficient delivery of operations and process optimization.
• Lead troubleshooting and repair efforts to return equipment to normal operation such as process control systems, electromechanical, pneumatics controls devices for manufacturing applications and utility support system.
• Assist manufacturing and facilities personnel in troubleshooting and diagnostic analysis on process and utility equipment.
• Capacity to function as an administrator for the CMMS for the site, overseeing all assets lifecycle records.
• Track KPI for work order completion and non-conformance trending, seeking resolution with assets owners in accordance with the planes schedule and business priority.
• Continuously evaluate instrumentation and calibration practices to eliminate nonproductive activities and implement cost effectives processes.
• Manage the acquisition and handling of standards, special tools, calibration equipment, spare parts and service levels of agreements to support the site's operation.
• Write, revise and review Standard Operating Procedures, adhering to schedules and interfacing in a constructive manner with all vendors, contractors, associates, peers, and managers.

Benefits

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage in accordance with the terms of the applicable plans
• short-term incentive bonuses
• equity-based awards for salaried roles
• commissions for sales roles

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees