SHL Medical is a world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5,000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018.
Taiwan has been SHL's starting ground in our bid for global mobility in the fields of drug delivery and medical technology. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the delivery of modern precision medicine.
Job Overview
To perform all maintenance and operations of SHL medical device manufacturing facilities. Responsible for ensuring the smooth operation of all equipment and machinery in the facility.
Main Responsibilities
- Support facility buildout for commissioning and Qualification activities.
- Follow all SHL Medical OSHA, and EPA safety guidelines.
- Capable of managing outside contractors.
- Experienced in the following: Air Handling Unit, Compressed Air System, Cooling Tower, Heating Hot Water Boilers, Chillers, Heat Exchanger, Electrical, Emergency Generator, and any other subsystem that will be used to support the manufacturing operation.
- Provide operational support to facility Services, Engineering, Manufacturing, Research and Development, and other SHL Medical organizations.
- Operate Utility systems and subsystems at SHL Medical Manufacturing Facility. Ensure that equipment always remains in its designed and validated state and that its operation is in accordance with the Federal, and state inspection readiness, specifically related to but not limited to personnel and equipment safety, compliance requirements.
- Support facility investigations to help determine deviation root causes, recommended immediate mitigation, and long-term preventative strategies.
- Responsible for operating all facility systems/equipment in the entire campus, and managing workload to support the whole operation, identifying spare parts requirements and support staff, maintaining operational records.
- Working knowledge of the BMS (Building Management System), and EMS (Environmental Monitoring System).
- Solve a wide range of difficult issues that impact multiple functions following SHL Medical standard procedures by applying basic theory and technical principles.
- Troubleshoot mechanical and electrical failure up to 480V
- Interface with the Facilities, Engineering and Capital Project Management, Quality /assurance, Quality Control, Regulatory Compliance, EH&S, and Manufacturing.
- Execute and complete all preventive, and predictive maintenance and assign paperwork in a timely manner, following all cGMP documentation guidelines.
- Respond to alarms and evaluate incidents involving mechanical, electrical, and system controls.
- Assist in the completion of Quality Assurance Change Control
- Responsible for ensuring that all relevant SOPs and operating parameters are followed, and maintenance activities are properly documented utilizing GDP.
- Perform JSA in the maintenance area.
- Must be able to execute any work orders in the field.
- Makes recommendations to help simplify and facilitate ongoing maintenance repair.
- Regularly interact with the facility team and stakeholders. These include performing PMs on production and utilities.
- Support of automated control systems in manufacturing and facilities, including process control and building management support systems including work order changes, Validation, SAT, IQ, OQ, and PQ support for the new and existing systems.
- Perform preventive maintenance and equipment servicing according to Standard Operating Procedures. Provide recommendations for system upgrades.
- Submit an appropriate change request to correct any deficiencies discovered during PM execution.
- Must understand the Confine Space Entry, LOTO, and any other Safety protocols
- Must be able to minimize breakdowns and repairs (performing quality checks of all machinery, tools, equipment, etc.)
- Must be able to support Facility maintenance, and shutdown during holidays, and off hours.
- Must be able to work Weekend and Holidays
Skills and Qualification
- High School or AA degree or At least 5 years of experience in a facility maintenance role, preferably in a medical device manufacturing facility.
- Strong knowledge of maintenance best practices, including preventative maintenance, predictive maintenance, and reliability-centered maintenance
- Excellent communication and interpersonal skills.
- Strong problem-solving skills, with the ability to identify and resolve complex maintenance issues.
- Ability to work independently and make decisions with minimal supervision.
- Knowledge of relevant regulatory requirements, including FDA regulations and ISO standards
- Able to work 7am to 7pm or 7pm to 7 Am, rotating days 24/4.
Disclaimer: This job description provides a high-level job definition. It is not intended to provide a comprehensive or exclusive list of job duties. As such, job duties and/or responsibilities within the context of this job requisition may change at the discretion of the employee's direct supervisor.
Physical Demands:
- The physical demands described here are representative of those that must be met by the employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- While performing the duties of this job, the employee is regularly required to, stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach.
- Specific vision abilities required by this job include close vision requirements due to computer work.
- Light to moderate lifting is required.
Work Environment:
- The work environment characteristics described here are representative of those the employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- Moderate noise (i.e. business office with computers, phones, and printers, light traffic).
- Ability to work in a confined area.
- Ability to sit at a computer terminal for an extended period.
Travel or Special Requirements:
- During the workday as well as local, out-of-state, and/or international travel may be required to perform job duties.
- Be able to work Holidays and Weekends schedule and off hours if necessary.
Interested in joining SHL Medical and in supporting us with your expertise and personality? We look forward to receiving your application including your CV, motivation letter, and all other relevant documents via the Easy Apply button or directly to ...@shl-group.com.
For more information on SHL Medical, please visit: linkedin.com/company/shlmedical/life
Is this not quite what you are looking for? Further interesting career opportunities can be found on: shl-medical.com/careers
Please note: We do not consider applications from recruitment agencies for this position.