Maintenance Technician IV, Lead (Days)
Resilience
Summary
The Lead Maintenance Technician IV is responsible for leading and 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. This role requires the ability to perform mechanical and electrical troubleshooting in order to ensure optimal operation of the process equipment. The Lead Maintenance Technician will also perform basic mechanical training to Process Maintenance Technician and serve as a resource to help implement continuous improvement projects. The Lead Maintenance Technician is a position reporting to a Supervisor, Maintenance.
Job description
Job Responsibilities
- 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.
- Complete and Review documentation and required functions in the work order system to close out activities in compliance with cGMPs.
- 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.
- Provide training to operators and Process Maintenance Technicians for equipment set-up and for major and minor adjustments or repairs.
- 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 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 in performance of job responsibilities. This will include mathematical computation where needed.
- Perform roles of Technician and Mechanical Technician as required to support daily PET activities.
- Teach appropriate Problem Solving and Troubleshooting techniques to complete equipment repairs.
- Follow and maintain compliance with established MRO procedures and inventory control.
- Serve as a project resource to PET to assist in the follow up and timely implementation of projects and validation activities.
- Responsible for maintaining Aseptic Processing and Gowning certifications as required to support assigned work areas. (Area Dependent)
- 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.
Some overtime will be required with prior notice to support business needs. Emergency overtime may be required with little notice to ensure operation of equipment within the PET.
Education, Qualifications, Skills and Experience
Minimum Requirements:
- Significant experience in a regulated production environment, specifically responsible for equipment maintenance and performance.
- Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language.
- Ability to lift and handle equipment change parts, tooling, and materials associated with equipment maintenance and repair.
- Proficient with Computerized Maintenance Management Systems such as Maximo or SAP.
- Ability to lead a small team of technical resources in a cGMP environment.
Preferred Background:
- High school graduate, vocational school graduate or equivalent.
- Associate degree in engineering or a related discipline or equivalent mechanical trade school graduate preferred.
- Previous experience with automated equipment preferred.
- Training in mechanics, hydraulics, electronics and testing equipment in electrical and/or mechanical troubleshooting.
- Knowledge of data and materials maintenance systems such as Maximo, SAP, ADP, KRONOS, or other MRP systems.
- Experience with OEE, TPM, LEAN or other Continuous Improvement systems.
- Planning and Scheduling knowledge.
- Previous leadership experience in a manufacturing environment.
Requirements
- Significant experience in a regulated production environment, specifically responsible for equipment maintenance and performance
- Ability to effectively understand, read, write, communicate, and follow instructions in the English language
- Ability to lift and handle equipment change parts, tooling, and materials associated with equipment maintenance and repair
- Proficient with Computerized Maintenance Management Systems such as Maximo or SAP
- Ability to lead a small team of technical resources in a cGMP environment
- High school graduate, vocational school graduate or equivalent
- Associate degree in engineering or a related discipline or equivalent mechanical trade school graduate preferred
- Previous experience with automated equipment preferred
- Training in mechanics, hydraulics, electronics and testing equipment in electrical and/or mechanical troubleshooting
- Knowledge of data and materials maintenance systems such as Maximo, SAP, ADP, KRONOS, or other MRP systems
- Experience with OEE, TPM, LEAN or other Continuous Improvement systems
- Planning and Scheduling knowledge
- Previous leadership experience in a manufacturing environment
Benefits
- Annual cash bonus program
- 401(k) plan
- Company match
- Medical insurance
- Dental insurance
- Vision insurance
- Family building benefits
- Life insurance
- Disability insurance
- Paid vacation
- Paid holidays
- Paid leaves of absence
- Tuition reimbursement
Company overview
Resilience (National Resilience, Inc.) is a technology-focused contract development and manufacturing organization (CDMO) dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure that advanced therapies can be made quickly, safely, and at scale. Resilience specializes in manufacturing complex modalities including biologics, vaccines, nucleic acids, cell and gene therapies, and drug products. With facilities across North America, the company partners with leading biopharma companies to bring innovative medicines to market faster and more reliably. Their capabilities span biologics drug substance manufacturing, cell-based therapies, and aseptic drug product manufacturing for both small and large molecules. Resilience's mission is to free its partners to focus on scientific discoveries while advancing the science of biopharmaceutical manufacturing through cutting-edge technologies and integrated digital systems.