Lead Manufacturing Technician

About the role

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 which could apply. You will fully participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the supervisor, this position shall be responsible for the hands-on execution of all activities in the production area.

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
• Cookordinate with other groups such as maintenance/metrology to ensure preventative maintenance is done per plan
• May perform other duties as assigned

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.

Qualifications

• High school diploma or GED required; Associate degree or higher preferred
• Minimum 6+ years of manufacturing experience in a regulated environment, or 4+ years of related experience with an Associate degree or higher
• Previous experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments preferred
• 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
• Hands-on experience operating and troubleshooting pharmaceutical manufacturing equipment, including filling, inspection, packaging, filtration, or autoclave systems preferred
• Able 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
• Experience utilizing manufacturing and business systems such as EBM, JDE, or similar electronic systems preferred
• 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
• Able to perform quantitative analysis and interpret production/process data to support operational improvements

Skills

• Excellent written and verbal communication skills
• Understanding of cGMP regulations
• Exceptional procedural writing skills
• Skilled with pharmaceutical production equipment
• Quantitative analysis skills
• Leadership experience
• Hands-on experience with manufacturing equipment
• Collaborative teamwork skills
• Computer proficiency
• Organizational and interpersonal skills
• Safe manufacturing practices
• Quantitative analysis and data interpretation skills

Benefits

At Takeda, we offer a comprehensive benefits package including:

• Medical, dental, and vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits

Pay

The estimated hourly wage range for this position is $28.99 - $45.53. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

Schedule

This role is a day shift, 5:00am – 5:30pm in a 2-2-3 work schedule configuration.