Lead, Instrumentation & Calibration

AstraZeneca • Rockville, MD

1d

About The Position

Lead Instrumentation and Calibration (I&C) As Lead Instrumentation and Calibration, you’ll ov ersee 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. Responsibilit ies: 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 p lanes 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 sta ndards, special tools , calibration equipment, spare p arts 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.

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
• E xtensive knowledge of cGMP standards, in particular manufacturing, laboratory and requirements for computer systems (GAMP) and data integrity
• Excellent written and verbal communication skills

Responsibilities

• Planning and scheduling of all routine and non-routine calibration events
• Business Process Owner for Instrumentation and Calibration activities
• Development and implementation of the site’s Instrumentation and Calibration strategy
• Proactive day-to-day management and performance development of the instrumentation and calibration teams
• Lead troubleshooting and repair efforts to return equipment to normal operation
• Assist manufacturing and facilities personnel in troubleshooting and diagnostic analysis on process and utility equipment
• 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
• Continuously evaluate instrumentation and calibration practices to eliminate nonproductive activities and implement cost effectives processes
• Manage the acquisition and handling of sta ndards, special tools , calibration equipment, spare p arts and service levels of agreements to support the site's operation
• Write, revise and review Standard Operating Procedures

Benefits

• 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.

What This Job Offers

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