This position is responsible for work crew leadership for the maintenance of aseptic and packaging manufacturing systems through the application of generally accepted maintenance tradecraft skills (e.g., mechanical, electrical, etc.). Specifically, to direct and oversee work assignments to Maintenance technicians under the guidance and direction of Maintenance supervision. Ensures proper documentation of activities through procedures and guidelines developed by Maintenance management.
Essential Duties & Responsibilities Percentage of Time
Holds work crew responsible for installation, preventive maintenance, emergency repairs and modifications / upgrades of hydraulic, pneumatic, electrical, electronic, and mechanical systems pertaining to aseptic and/or packaging equipment. Will assist and consult technicians on technical issues used in troubleshooting equipment.
Troubleshoots equipment and process problems with ability to resolve expeditiously and in a quality manner. Expedites the repair of aseptic and packaging equipment through the allocation of the department's physical and personnel resources.
Ensures cGMP guidelines, safety procedures, and SOP's are followed at all times for the work crew. Maintains a clean work area adhering to all good housekeeping regulations. Monitors correctness of SOP's and PM's and will revise SOP's as needed. Trains and instructs, per SOP's and related documents, technicians in the maintenance and operation of equipment and all other job functions within assigned areas under the guidance of Maintenance management
Report employee relations problems to the Supervisor and works with the Supervisor in resolving all issues on the floor . Provides input to the Maintenance Supervisor/Manager regarding performance appraisals of subordinate hourly technicians.
Review log books, PM's, and work orders and ensure all entries are complete and correct.
Assists Maintenance management in communications, both written and verbal, to applicable departments.
Assist Maintenance management with recommendations pertaining to equipment upgrades, maintenance, enhancements, analysis of operation parameters of equipment and processes, and other requirements to support manufacturing operations. Hands-on involvement with equipment and technician is an ongoing responsibility.
Procures essential maintenance supplies, tools, and critical equipment spare parts and components necessary for Maintenance operations.
Other duties, as assigned, or as business needs require.
Ensure maintenance systems are in appropriate compliance.
Support operational readiness and effectiveness of manufacturing systems.
Maintain the validated states of manufacturing systems. Adheres to all applicable cGMP standards and requirements.
Effectively work with the maintenance organization and maintenance management
Effective communication with groups outside of maintenance.
Provide floor leadership and presence for Maintenance technicians.
High school / GED education, two (2) years technical schooling
A.A. or A.S. degree or vocational courses in areas such as welding, mechanics, electrical, control systems, etc.
Minimum of 3 year in a pharmaceutical manufacturing environment as a mechanic or technician.
Minimum of 7 years in a high volume manufacturing environment as a mechanic or technician.
Knowledge of cGMPs, change control processes, FDA-regulated industry documentation practices, electronic database packages (e.g., CMMS/AMMS, Blue Mountain, etc.), inventory systems.
Previous 3 years lead experience within biopharmaceutical manufacturing or maintenance.
Specialized or Technical Knowledge Licenses, Certifications needed:
Computer skills- Windows XP, Excel, Word.
Effective oral/written communication skills in English with the ability to interface with all levels of personnel.
Operate heavy equipment such as a forklift.
Possess knowledge and experience in working in a maintenance group or environment of a high-volume manufacturing company.
A technical knowledge and understanding of pharmaceutical production equipment, lyophilization, pharmaceutical facilities and utilities. Examples include washers, fillers, autoclaves, cappers, conveyors, vision systems, etc. Areas include the operation, mechanical/electrical/controls design, servicing requirements, spare parts requirements, etc.
Knowledge and practical application experience of pharmaceutical manufacturing equipment and systems requirements, equipment validation, lyophilization, vial and syringe filling, container closures, cleaning and sanitization processes, etc., and the creation of documentation in support of these areas.
Demonstrate subject-matter-expert (SME) qualities in at least two classifications of equipment, process, or technology. Provide technical feedback and guidance on equipment/process issues as required.
Planning and Organization
Ability to adapt to a dynamic environment and handle multiple activities/projects at one time. Handle multiple priorities and effectively meet company based goals.
Must have good cGMP documentation practices. Demonstrates good writing skills.
Ability to appropriately delegate tasks and activities to technicians as needed.
Ability to communicate verbal and written communication within and outside the maintenance organization.
Able to work on teams and take direction and guidance from supervisor and management.
Be customer-service focused.
Effective in interfacing with assigned Maintenance crew or shift. Ability to evaluate group dynamics and identify technical strengths and weaknesses of the crew or shift.
Ability to solve technical problems- mechanical, electrical, controls, hydraulics, etc. Apply effective problem solving techniques in determining assignable cause(s) with recommended corrective action(s).
Demonstrates good verbal and written skills commensurable with all levels within the Irvine site.
Autonomy and Independence
Must be self-motivating, resourceful, and independent.