Maintenance Technician IV, Lead - Sterile Operations (Nights)

Resilience•West Chester, OH

1d•$29 - $47

About The Position

The Maintenance Technician IV, Lead – Sterile Operations performs ongoing corrective, predictive, and preventative maintenance on process equipment in an assigned operating area. The role may also provide setup and changeover support for process equipment in classified areas, including Class 100 aseptic environments. It requires mechanical and electrical troubleshooting to help ensure optimal equipment operation. The Lead serves as a first-line resource for the maintenance team, takes point on daily floor maintenance activities, helps ensure the team’s work orders and GMP documentation are accurate and complete, drives continuous improvement, and collaborates with Management and Engineers to support compliant and efficient process equipment operation. The position also includes training technicians and operators, coordinating team activities, supporting projects and validation, and maintaining required aseptic processing and gowning qualifications. The role is primarily non-sedentary and may involve climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects. It may require use of respirators, PAPRs, gowns, gloves, face protection, and other protective equipment, as well as participation in an occupational health program. The expected schedule is 2-2-3 Night D shift; the company may modify schedules and may request overtime based on business needs. Work authorization sponsorship is not available.

Requirements

Demonstrated experience performing corrective, preventative, and predictive maintenance on automated process equipment in a regulated GMP environment.
Mechanical and electrical troubleshooting proficiency, including mechanics, hydraulics, pneumatics, and electronics.
Familiarity with aseptic or sterile manufacturing requirements, including gowning, environmental monitoring awareness, and clean room behavior.
Ability to independently diagnose and resolve equipment failures with limited supervision and make independent decisions regarding assigned maintenance work.
Proficiency with computerized maintenance management systems, such as Maximo or SAP, including creating, updating, and closing work orders independently.
Ability to complete and review GMP documentation accurately, including work orders, batch records, and maintenance logs in accordance with cGMP requirements.
Ability to read and interpret electrical schematics, mechanical drawings, and equipment manuals.
Ability to understand, read, write, communicate, and follow instructions in English.
Demonstrated experience coordinating team activities and taking point on shared tasks with other maintenance technicians in a GMP manufacturing environment, including sound operational decision-making under pressure.
Demonstrated ability to train other technicians on equipment setup, operation, troubleshooting, and maintenance procedures.
Ability to demonstrate and maintain gown qualification standards.
Ability to perform a primarily non-sedentary role, including climbing, kneeling, repetitive motion, working through temperature changes, and exerting up to 100 pounds of force to move objects.

Nice To Haves

High school diploma or GED.
Associate degree or vocational/trade school certification in a relevant discipline, such as industrial maintenance, electrical, mechanical, or instrumentation.
4+ years of equipment maintenance experience in a regulated pharmaceutical or GMP manufacturing environment.
Experience with OEE, TPM, LEAN, or other continuous improvement methodologies.
Knowledge of data and materials systems such as Maximo, SAP, ADP, KRONOS, or other MRP/ERP systems.
Experience with automated sterile pharmaceutical manufacturing equipment, such as fill-finish lines, lyophilizers, autoclaves, isolators, or CIP/SIP systems.
Maintenance planning and scheduling knowledge.
Prior lead technician experience in a manufacturing maintenance environment.

Responsibilities

Lead emergency repairs, rebuilding, changeover, and inspection work on process-related equipment.
Install, inspect, test, adjust, repair, and perform line turnarounds, changeovers, and preventative maintenance according to established procedures.
Monitor data to support equipment and system performance in the assigned operating area.
Use testing, tools, and measuring equipment to maintain and troubleshoot electronic, environmental monitoring, pneumatic, hydraulic, and mechanical line equipment.
Lead installation of new equipment and oversee equipment upgrades according to site SOPs.
Lead and perform 5S activities and maintain organization of operating areas.
Perform Technician and Mechanical Technician duties as needed to support daily PET activities.
Support PET projects and the timely implementation of projects and validation activities.
Perform cleaning and housekeeping activities as required to maintain a cGMP environment.
Complete work order system documentation and help ensure other maintenance technicians' documentation is accurate and complete.
Perform work in compliance with SOPs, cGMPs, OSHA requirements, and established safety procedures; reinforce compliance across the team.
Maintain familiarity with Material Safety Data Sheets for area chemicals.
Complete batch record and GMP documentation entries, help other technicians identify documentation errors, and maintain required records and logs, including mathematical computations when needed.
Follow MRO procedures and maintain inventory control.
Maintain Aseptic Processing and Gowning certifications as required for assigned work areas.
Act as a certified OJT trainer for assigned equipment and processes, providing hands-on training on setup, adjustments, and repairs.
Teach problem-solving and troubleshooting techniques for equipment repairs.
Use situational judgment and operational decision-making to coordinate team activities and support the supervisor with issue communication and escalation.
Lead daily floor maintenance execution, coordinate area activities with teammates, and communicate between shifts.
Provide technical support to production operators and maintenance technicians and collaborate with Management and Engineers to maintain a compliant, efficient operating environment.
Perform other similar and related responsibilities as assigned by area management.