Maintenance Technician IV - Sterile Operations

Resilience; Olde West Chester (OH); On-site; USD 81,664,000 - 133,241,000; Full time

Benefits offered by this job

Health insurance

401(k) plan with company match

Paid time off

Job summary

Resilience, located in West Chester, Ohio, is seeking a Maintenance Technician to support cGMP manufacturing operations. The role focuses on corrective, preventive, and predictive maintenance of automated process equipment, with a strong emphasis on troubleshooting electrical and mechanical systems and maintaining documentation.

The ideal candidate will have GMP experience, be proficient with CMMS (Maximo, SAP), and able to operate with minimal supervision while ensuring compliance and safety in

Qualifications

• Demonstrated experience performing corrective, preventative, and predictive maintenance in GMP.
• Proficient in mechanical and electrical troubleshooting incl. hydraulics and pneumatics.
• Able to read electrical schematics and equipment manuals.
• Experience with CMMS systems (Maximo, SAP) for work orders and logs.
• Familiarity with aseptic/sterile manufacturing environments and gowning procedures.

Responsibilities

• Perform corrective, preventive, and predictive maintenance on process equipment in a GMP setting.
• Troubleshoot mechanical, electrical, hydraulic, pneumatic, and electronic systems.
• Install, test, inspect, and repair equipment and perform line changeovers and PMs.
• Maintain cGMP compliance through proper documentation in work orders and batch records.
• Provide training to operators on equipment setup and minor repairs.

Skills

Electrical troubleshooting

Mechanical troubleshooting

GMP/compliance

CMMS (Maximo/SAP)

Attention to detail

English communication

Education

High school diploma or GED

Associate degree or vocational certification

Tools

Maximo

SAP

Job description

A career at Resilience is more than just a job – it’s an opportunity to change the future.

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

Job Responsibilities

Operations

• 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.
• Install new equipment and oversee equipment upgrades according to site SOPs.
• Perform 5S activities and maintain organization of operating areas.
• Work with minimal supervision under the direction of the Maintenance Supervisor, Process Supervisor/Manager, Engineer, or other activity leads.
• Perform roles of Technician and Mechanical Technician as required to support daily PET activities.
• Utilize appropriate Problem Solving and Troubleshooting techniques to complete equipment repairs.
• 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.

Documentation & Compliance

• Complete documentation and required functions in the work order system to close out activities in compliance with cGMPs.
• Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs, and established safety procedures in accordance with OSHA requirements and guidelines.
• Be familiar with Material Safety Data Sheets for area chemicals.
• Perform batch record and GMP documentation entries. 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.

Training & Development

• Provide training to operators for equipment set-up and for minor adjustments or repairs.
• Responsible for maintaining Aseptic Processing and Gowning certifications as required to support assigned work areas (area dependent).

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; make 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.

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).

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

[12 hour – 2/2/3]

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.

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.