Summary
Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of cGMP production equipment, clean utilities and plant utility systems. Assist with engineering and evaluation of existing and new equipment and processes.
Job Responsibilities
Essential
Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
Make appropriate adjustments or modifications within company and GMP guidelines and notify supervisor of any abnormal parameters.
Collaborate with department teams to complete specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
Provide general labor services throughout all areas maintained by the Maintenance department.
Responsible for providing data to derive performance metrics for management that will be gathered on a daily basis for monthly reporting.
Assist as a technical SME with identification, purchase, and organization of spare parts.
Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing and utilities equipment.
Cleaning and organization of designated work areas in Manufacturing and Utilities.
Complete GMP and other controlled documentation.
Revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
Interact with Manufacturing, Instrumentation, Metrology and Engineering staff members as well as other internal/external customers.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Follows established safety and environmental guidelines and procedures for all work performed.
Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Fosters a positive safety culture in which no one gets hurt.
Job Requirements
Education and Experience
High school graduate.
5 years general mechanical maintenance experience and minimum 3 years in a highly regulated environment.
Knowledge, Skills, and Abilities
Mechanical Aptitude
Self starter with good time management skills
Good communication skills, both written and oral.
Prompt, consistent and orderly work habits.
Ability to read and interpret P&ID drawings
Overall knowledge of mechanical, pneumatic, hydraulic, refrigeration, steam, electrical systems, controls, and maintenance methods. Specializing in at least one
General troubleshooting skills
Ability to work independently on all but complex or controversial issues.
Ability to interact well with others in a team environment.
Strong organizational skills and time management skills.
Ability to learn and use Microsoft based platforms and/or company Intranet and e-mail.
Ability to use computer software applications like Google Suite (MS Word/Excel).
Ability to use Building Management Control System (BMCS) and Manufacturing Control System (MCS)
Building Management system experience is a plus
Delta V experience is a plus
Available to work overtime when necessary and work varying shifts
General knowledge of shop tool operation and safety.