SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 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 in late 2018, with sites in Sweden, Taiwan, and the United States.

Job Overview

To oversee and manage the maintenance operations of SHL medical device manufacturing facilities. Be responsible for ensuring the smooth operation of all equipment and machinery in the facility, managing maintenance staff, and developing and implementing effective maintenance programs.

Main Responsibilities

• Knowledge in GDP (ALCOA) cGMP, 11CFR, ISO8, ISO9
• Must be able to lead and or support facility System Commissioning and Qualification activities including generation of CTP, and system qualification.
• Must be able to maintain Air conditioning and refrigeration, troubleshoot, and repair equipment from the smallest DX unit to the largest climate control systems in State-Of-The-Art medical facility.
• Must be able to install, maintain, and service ice machines, walk-in coolers, refrigerated water coolers, etc.
• Must be able to support and have Knowledge in Facility Utility Systems that include day-to-day operation, maintenance, and troubleshooting of the facility utilities, Cooling Tower, Chillers, Compress Dry Air, Air Handling Unit, Heating Hot Water Boiler, Electrical and process area improvements.
• Highly proficient in operating the BMS, EMS control systems. Must be able to Troubleshoot, Operate Perform Maintenance (Predictive & Preventive), and Alarm response using BMS, EMS, and or Local alarm (s).
• Good interpersonal and communication skills are important. You must be able to stop, bend, climb, and work in awkward positions. Good eyesight, manual dexterity, hand-eye coordination, and the ability to concentrate are required.
• Develop and implement WI (Work Instruction), Standard Operation Procedure to ensure the efficient operation of the HVAC systems.
• Support facility investigations to help determine deviation root causes using RCA, recommended immediate mitigation/CAPA.
• Must Support continuous improvement projects to improve the safety, robustness, and compliance of the facilities and utilities supporting the entire facility manufacturing site.
• Must be able to manage your own workload efficiently and identify spare parts requirements, provide training to entry-level mechanics and support staff, and maintain GDP and Compliance.
• Use data analysis to help analyze the root of the problem and potential problem by performing RCA and FMEA
• Must be able to provide the BKM (Best Known Method) in performing preventative and corrective maintenance.
• Understand and be familiar with general maintenance workflow processes, procedures, and systems.
• Interface with the Facilities, Engineering and Capital Project Management, Quality Assurance, Quality Control, EH&S, and Manufacturing Operation.
• Create and implement measures to minimize breakdowns and repairs (performing quality checks of all machinery, tools, equipment, etc.)
• Record and track daily progress/error reports using KPI.
• Perform Daily, weekly rounds on all Facility Utility systems. Identify any abnormalities, submit an emergency work order, and rectify any issue if necessary.
• Must be able to work “Holidays, Weekends, and or Off Hours and response and or work onsite during emergency calls.
• Must be able to work independently in a very fast-phase environment.

Skills and Qualification

• Highly Preferred EPA 608 and 609 Certified and or NATE Level 2-3 or Senior Level Efficiency Analyst Certification is a plus.
• AA degree and or JC vocational school that is related to the industry.
• 10-12 years of field HVAC experience and preferably in Biopharma, or Medical Manufacturing Facility
• Experience working with BMS, EMS, HVAC, CT, CDA, CHWS, and other systems that support manufacturing production.
• Excellent in troubleshooting, analyzing, and solving problems with various electrical, pneumatic, and hydraulic controls and systems.
• Must have Strong knowledge of Maintenance Best Practices: Preventative Maintenance, Predictive Maintenance, and Reliability-Centered Maintenance a plus.
• Highly preferred the candidate must have Dedication that includes a strong sense of support and loyalty to a business or career role.
• Must have confidence and productivity. Confident employees not only believe in their abilities to manage tasks and deliver high expectations to the organization.
• You must be a Team Player, which is a requirement in the FM organization, and have a successful collaboration that requires excellent communication skills, patience, tolerance, and dedication. Demonstrate strong teamwork skills and exhibit a series of other desirable skills. Being a team player is crucial when ensuring that you’ll be a positive addition to the current team.
• You must have the ability to work independently. Even in a heavily team-oriented organization, you must work on your own and be able to create trust between you and your manager and or coworker that you’ll complete the task individually (You must have Strong Focus, Time management Skills, Resourcefulness, and Ability to critique and edit your own work without breaching compliance and or cGMP protocols.
• Must have interpersonal/ Communication Skills, a high level of professionalism, an open-minded approach to new ideas, and the ability to interpret non-verbal communication.
• Proven track record of developing and implementing effective maintenance programs.
• You must have /Self-awareness with strong emotional intelligence that understands your role on your team and ask for and learn from feedback.
• Knowledge of local, state, and federal applicable regulations
• Excellent communication and interpersonal skills, with the ability to effectively manage and motivate staff.
• Strong problem-solving and analytical skills, with the ability to identify and resolve complex maintenance issues.
• Strong organizational and project management skills, with the ability to manage multiple projects simultaneously.
• Ability to work independently and make decisions with minimal supervision.
• Knowledge of relevant regulatory requirements, including FDA regulations and ISO standards.
• Knowledge in Lean 6S & Six Sigma, Continuous Cost Reduction, OEE improvements and Root Cause Analysis (RCA), and FMEA.
• Managed all aspects of the complete Project cycle for Capex, upgrade, and cost improvement initiatives from feasibility, user requirements, bid specification, plant floor layout, vendor selection, installation, commissioning, validation, documentation support, production handover, and training.

Reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential functions.

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:

• Driving during the workday, as well as local, out-of-state, and/or international travel, may be required to perform job duties.
• Must be able to work Holidays and Weekends schedule and off hours if necessary.

We offer:

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies.
• Challenging assignments in a fast-growing and innovative industry.
• Position in a dynamic, international team of highly skilled professionals.
• Various opportunities for personal and professional development within a global organization.

Please note: For this position, we do not consider applications from recruitment agencies.