Lead Manufacturing Technician

Takeda•Round Lake, IL

8d•Onsite

About The Position

As the Lead Manufacturing Technician, you will execute all processes in production while strictly adhering to cGMP, environmental health and safety guidelines, and any other related regulations that may apply. You will fully participate in both departmental projects and any applicable quality working teams. Under the general direction of the supervisor, this position is responsible for the hands-on execution of all activities in the production area. In addition to making routine revisions to documents, you will rewrite complex procedures or initiate new procedures as applicable. The incumbent possesses sufficient applied technical knowledge to perform complex troubleshooting tasks and may even assist during the transfer of new technologies into manufacturing. The position requires technical and administrative competence to organize and lead production activities, including demonstrating leadership in cGMP compliance and environmental health and safety skills. This role is a day shift, 5:00 AM – 5:30 PM, with a 2-2-3 work schedule configuration.

Requirements

Must be able to speak, read, write, and follow detailed written and oral instructions in English.
Must have excellent written and verbal communication skills and understanding of cGMP regulations.
Exceptional procedural writing skills, required.
Skilled with pharmaceutical production equipment including but not limited to autoclave.
Must be able to apply quantitative analysis to analyze process performance.
Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
Highly effective interpersonal skills and be able to work effectively and efficiently in a team environment.
Knowledgeable of chemical and biological safety procedures.
Good computer skills.
High school diploma or GED required
Minimum 6+ years of manufacturing experience in a regulated environment, or 4+ years of related experience with an Associate degree or higher.
Demonstrated leadership experience, including mentoring, coaching, or supporting production teams in a lead or supervisory capacity.
Strong understanding of cGMP/GDP regulations and manufacturing documentation practices.
Ability to support and coordinate manufacturing operations in a fast-paced production environment while maintaining a strong focus on safety, quality, and schedule adherence.
Strong problem-solving, troubleshooting, and decision-making skills with the ability to minimize operational downtime.
Effective written and verbal communication skills with the ability to work collaboratively across Manufacturing, Maintenance, Quality, and Engineering teams.
Proficient computer skills including Microsoft Office applications.
Strong organizational, interpersonal, and leadership skills with the ability to train and develop team members.
Knowledge of chemical and biological safety procedures and safe manufacturing practices.
Ability to perform quantitative analysis and interpret production/process data to support operational improvements.

Nice To Haves

Associate degree or higher preferred.
Previous experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments preferred.
Hands-on experience operating and troubleshooting pharmaceutical manufacturing equipment, including filling, inspection, packaging, filtration, or autoclave systems preferred.
Experience utilizing manufacturing and business systems such as EBM, JDE, or similar electronic systems preferred.

Responsibilities

Lead training efforts and mentoring for manufacturing tech progression from level 1-3
Conduct safety Gemba’s and provide coaching daily to ensure technicians are adhering to proper ergonomic techniques.
Support all local manufacturing operations.
Demonstrate proficiency in electronic systems such as (EBM, JDE, etc.)
Operate general production equipment (such as Filling, Inspection & Packaging equipment).
Ensure relevant paperwork following GDP/GMP guidelines.
Manually clean all portable equipment and small parts.
Participate on Continuous Improvement Teams.
Receive and distribute supplies into the production area as necessary.
Monitor daily cleaning of the production area to maintain in GMP fashion.
Assemble and operate filtration systems.
Ensure all components necessary for Manufacturing are prepped and ready to meet schedule adherence in addition to setting up incoming shift for success.
Troubleshoot process & equipment problems in a timely manner to minimize Manufacturing downtime.
Coordinate with other groups such as maintenance/metrology to ensure preventative maintenance is done per plan.
May perform other duties as assigned.