Manufacturing Lead

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 since late 2018, with sites in Sweden, Taiwan, and the United States.

Job Overview

The Manufacturing Lead will be responsible for leading all manufacturing activities with responsibilities for production, quality, shipping, receiving, and other production-related activities. Additionally, this individual will assist leading the manpower, equipment and material resources for all manufacturing operations at the facility.

Main Responsibilities

• Set up, perform changeover, and operate the production equipment and supplies in accordance with the established procedures and guidelines.
• Follow and document in MBRs to execute production processes.
• Operate equipment safely and effectively, following company policies for equipment operation.
• Ensure that equipment is maintained in good and safe working condition.
• Inspect equipment to identify any replacements, malfunctions, and repairs.
• Perform basic equipment maintenance to ensure production capacity and quality.
• Assists other operators in their assigned responsibilities.
• Assist with the training of other manufacturing operators.
• Evaluate equipment performance and recommend improvements
• Recommend process improvements to enhance operational efficiency and safety
• Identify and report unsafe operations to the supervisor immediately
• Maintain the work area clean, safe, and organized
• Be an SAP trainer (ability to train others on the SAP process)
• Read HMI screens on equipment to operate It.
• Lead 4-8 operators for Final Assembly, Labeling, Packaging on 1^st or 2^nd shift
• Troubleshoot any problems.  Escalate to supervisors/ME if assistance is needed.
• Maintain the Production schedule
• Work with ME for equipment changeovers, PMs, cms, and calibrations.
• Work with the warehouse on receiving, returning, and SAP Transactions on the material.
• Assist with forms, labels, NOE, NCR, ’s Filling out the batch record, and line reviews.
• Performs other related duties as assigned.

Skills and Qualification

• High School Diploma or equivalent to GED
• 3 years’ manufacturing experience in an FDA-regulated environment.
• Quickly adapt to new directions or new responsibilities as needed.
• Knowledge of cGMPs in an FDA-regulated environment., OSHA, and NFPA1 guidelines for safe practices.
• Analyzing and troubleshooting problems with equipment, identifying solutions, recommending, and implementing methods, procedures, and/or techniques for resolution.
• Maintaining a clean and orderly work area.
• Need to be extremely organized, logical, and methodical.
• Ability to spot imperfections or flaws in an assembled device.
• Must be able to distinguish colors and able to define defects.
• Visual acuity is necessary to do the job safely and effectively.
• Able to work overtime and weekends when needed.
• Able to lift 45lb boxes and work in refrigerators for extended periods given necessary PPEs.
• Be able to follow all PPE Requirements (gloves, safety glasses, safety shoes, and refrigerator jackets when needed).
• Able to stand for long periods. (Example over a 10-hour shift on concrete floors).

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

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents to our Talent Acquisition Department at RecruitUS@shl-group.com.

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