Manufacturing Supervisor - Injection Molding - SHL Medical : Job Details

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

This role is embedded in Production / Injection Molding of our new state-of-the-art device manufacturing facility in North Charleston, South Carolina. For interested candidates there will be an opportunity to initially spend an extended period in our facility in Taiwan for induction/training.

Main Responsibilities

• Supervise personnel and operations involved in medical device component injection molding
• Strict adherence to current Good Manufacturing Practice (cGMPs), established manufacturing practices and procedures, and compliance with Quality regulations and guidelines.
• Supervise all manufacturing activities and ensures safe operation of the molding department
• Coordinate and support molding production planning
• Review, trains molding Manufacturing Technicians
• Prepare documentation associated with the job duties of the department
• Ensure operations and practices comply with established procedures and records
• Ensure in-process tests and inspections are performed in accordance with standard procedures
• Assure accurate and complete production records; support documentation of production data and event/issue handling records
• Provide input during Health Authority inspections
• Acquire technical expertise on the function and control of applicable department equipment and techniques related to job function, and regulatory requirements for the molding operations
• Support evaluation, specification, installation, and validation of new manufacturing equipment as needed
• Maintain validated systems and re-validates existing systems in accordance validation procedures
• Incorporate value improvement programs and new processes from Engineering, EH&S, and OE as directed
• Serve as project member or project leader on improvement programs as needed
• Support manufacturing activities in other departments as instructed by manager
• Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes

Required Qualifications

• Bachelors Degree or equivalent experience
• Minimum 10 years injection molding-manufacturing experience; preferably related to high-volume manufacturing of medical device manufacturing
• Knowledge and experience in turnkey operation of (automated) production (hot runner molding and/or Robot handling) and related planning/logistics operations
• Ability to lead people and projects is required
• Excellent communication skills and ability to work in teams

Desired Qualifications

• Experience in an FDA regulated manufacturing environment
• Ability and experience with automated records systems such as MES, EWM and SAP
• Experience in planning/organizing work, managing execution, checking results & revising the work plan in accordance with the daily work plan

Physical Demands

• Ability to move equipment and/or supplies weighing up to 50 pounds within the facility using various body positions
• Routinely operates and inspects manufacturing equipment using hands
• Ability to be on feet for up to a 12-hour shift
• Corrected vision to 20/30
• Occasionally ascends/descends a ladder to service equipment; ability to work atop elevated positions
• Occasionally works around odorous and/or hazardous materials. May be required to wear latex gloves
• Occasionally positions self within confined spaces for inspection, repair and maintenance of equipment
• Ability to work in loud noise environments with hearing protection
• (Ability to attain clean room gowning certification and work with hazardous materials, including sanitants)
• Frequent bending, stooping and prolonged working overhead
• Ability to work the hours necessary to support a 24/7 continuous manufacturing operation

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 via the Easy Apply button or directly to [email protected].

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.