Manufacturing Lead

Shift: 1pm-9:30pm

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

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 1st or 2nd 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
• 1-2 years’ manufacturing experience in FDA regulated environment.
• 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.

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 that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

For more information on SHL Medical, please visit: shl-medical.com