About the role:
The Lead Manufacturing Technician reports to the Manufacturing Supervisor. You are responsible for executing 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. In addition to making routine revisions to documents, you will rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting 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.
How you will contribute:
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.
What you bring to Takeda:
High school diploma or GED. 6+ years of experience or AA or higher with 4+ years related work experience.
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.
In general, the position requires a combination of sedentary work and walking around observing conditions of the facility.
Must be able to carry up to 30lbs, lift up to 30lbs, push/pull up to 30lbs (with assistance of material handling equipment).
Must be able to stand and/or walk for an extended period over an 8-12 hour shift between rooms and across the site.
May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.
Repetitive motions with hands, wrists, turning head, bending at knees and waist.
20/20 near and distance vision (Applies to roles performing visual inspection only) with or without glasses and/or contacts.
Must be willing and able to work 12 hour shifts according to rotating 2-2-3 yearly shift calendar: day shift 5am -5:30 pm and night shift 5:00pm to 5:30am
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Professional training and development opportunities
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
Indoor working conditions and exposure to loud noises that requires hearing protection.
Will work around moving equipment and machinery.
May be required to work in controlled environments requiring special safety gear or gowning; will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, nail polish, or artificial fingernails may be worn in the manufacturing environment.
May be required to work in confined spaces/areas.
Some Clean Room and/or cool/hot storage conditions. (Applies to roles in Filling Department only).
May be exposed to and must not be allergic to cephalosporin. (Applies only to product touch roles - remove for all other roles).
Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.
Must be able to work on multiple shifts, including weekends and holidays, to support a 24/7 manufacturing operation as needed.
Must be able to work a 12-hour shift (5:00am - 5:30pm or 5:00pm - 5:30am), in a 2-2-3 rotation.
Must be able to work non-traditional work hours, including weekends and holidays, as needed.
Must be able to work overtime as required.
May require immunization before performing work within the manufacturing area.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This posting excludes Colorado applicants.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
USA - IL - Round Lake - Drug Delivery