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Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

The Maintenance Technician IV, Lead – Sterile Operations is responsible for performing ongoing corrective, predictive, and preventative maintenance for the process equipment within the assigned operating area. This position also could entail the execution of setup and changeover support for all process equipment used in various classified areas up to a Class 100 aseptic environment. It requires the ability to perform mechanical and electrical troubleshooting in order to ensure optimal operation of the process equipment. In addition, the Lead serves as the first-line resource for the maintenance team, leads daily floor maintenance activities, helps ensure work order and GMP documentation completed across the team is accurate and complete, drives continuous improvement, and collaborates with Management and Engineers to ensure compliant and efficient operation of the process equipment.

Job Responsibilities

Operations

• Lead the effort to complete emergency repair, rebuilding, changeover, and inspection work on process-related equipment. Install, inspect, test, adjust, repair, and perform line turnarounds, changeovers, and preventative maintenance per established procedures in a timely and efficient manner.
• Responsible for equipment and system performance through data monitoring within the assigned operating area.
• Use a variety of testing, tools, and measuring equipment in the efficient maintenance and troubleshooting of electronic, environmental monitoring, pneumatic, hydraulic, and mechanical line equipment.
• Lead the effort to install new equipment and oversee equipment upgrades according to site SOPs.
• Lead and perform 5S activities and maintain organization of operating areas.
• Perform roles of Technician and Mechanical Technician as required to support daily PET activities.
• Serve as a project resource to PET to assist in the follow up and timely implementation of projects and validation activities.
• Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
• Perform other similar and related responsibilities as assigned by area management.

Documentation & Compliance

• Complete documentation and required functions in the work order system, and help ensure documentation completed by other maintenance technicians is accurate and complete, to close out activities in compliance with cGMPs.
• Perform work in a responsible manner, and help reinforce compliance with SOPs, cGMPs, and established safety procedures in accordance with OSHA requirements and guidelines.
• Be familiar with Material Safety Data Sheets for area chemicals.
• Complete batch record and GMP documentation entries, and help other technicians catch errors in their entries before submission. Maintain records and/or logs as required. This will include mathematical computation where needed.
• Follow and maintain compliance with established MRO procedures and inventory control.
• Responsible for maintaining Aseptic Processing and Gowning certifications as required to support assigned work areas (area dependent).

Training & Development

• Act as a certified OJT trainer on assigned equipment and process tasks; provide hands-on training to operators and Process Maintenance Technicians on equipment set-up and major and minor adjustments or repairs.
• Teach appropriate problem solving and troubleshooting techniques to complete equipment repairs.
• Apply situational judgment and daily operational decision-making to help coordinate team activities, and support the supervisor in communication and escalation of issues and solutions.
• Take point on daily floor maintenance execution, coordinate with teammates on area activities, and maintain communication between shifts to ensure successful operations.
• Serve as a go-to technical resource for the team, providing support to production operators and maintenance technicians, and collaborate with Management and Engineers to maintain a compliant, efficient operating environment.

Education & Experience

Minimum Qualifications

• Demonstrated experience performing corrective, preventative, and predictive maintenance on automated process equipment in a regulated GMP environment.
• Demonstrated mechanical and electrical troubleshooting proficiency, including mechanics, hydraulics, pneumatics, and electronics.
• Familiarity with aseptic/sterile manufacturing environment requirements including gowning, environmental monitoring awareness, and clean room behavior.
• Ability to independently diagnose and resolve equipment failures with limited supervision; makes independent decisions regarding own maintenance work.
• Proficient in Computerized Maintenance Management Systems (e.g., Maximo, SAP); independently operates CMMS to create, update, and close work orders.
• Demonstrated ability to complete and review GMP documentation accurately, including work orders, batch records, and maintenance logs per cGMP requirements.
• Ability to read and interpret electrical schematics, mechanical drawings, and equipment manuals.
• Ability to effectively understand, read, write, communicate, and follow instructions in the English language.
• Demonstrated experience coordinating team activities and taking point on shared tasks alongside 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.

Preferred Qualifications

• High school diploma or GED Associate degree or vocational/trade school certification in a relevant discipline (e.g., industrial maintenance, electrical, mechanical, instrumentation) preferred.
• 4+ years of experience in equipment maintenance within 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 (e.g., fill-finish lines, lyophilizers, autoclaves, isolators, CIP/SIP systems).
• Planning and scheduling knowledge in a maintenance context.
• Prior lead technician experience in a manufacturing maintenance environment.

Physical & Work Environment

• This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
• Visual acuity such as working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.
• Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing.
• Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.
All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

Work Schedule

2-2-3 Night D shift
The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $28.50 - $46.50 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.

As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester.