About the role:
Under the direction of the Manager, contribute to the reliability, design, development and enhancement of manufacturing and support equipment. Contributes to improving the reliability of equipment, utilities, critical systems, and maintenance processes by applying the principles of Reliability Centered Maintenance. Participate in applying Root Cause Analysis methodologies to improve equipment that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. Investigate major equipment failures and contribute to developing action plans to prevent recurrence. Measure reliability performance and demonstrate success of improvements. Support capital projects as needed.
How you will contribute:
Create the maintenance SOPs, parts lists, BOMs and frequencies for new and modified equipment.
Recommend the optimal maintenance and calibration strategies for equipment, utilities and facilities based on their classification and criticality, including preventive maintenance, condition-based maintenance, and predictive maintenance.
Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment.
Perform data analysis of corrective work orders in CMMS to identify trends and area focus for improvements.
Perform functional equivalency assessment of spare parts.
In collaboration with engineering, manufacturing, and maintenance personnel r support troubleshooting of equipment.
Participate in Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA).
Execute Reliability Centered Maintenance (RCM) improvement projects in assigned area.
As requested, assist in the preparation of and/or participation in technical reviews of equipment design projects and FAT and commissioning of new or modified equipment
Complete change control, Quality CAPA and Safety CAPA tasks as assigned
Report project and operational metrics.
What you bring to Takeda:
Bachelor's degree in engineering discipline required.
2+ years of related experience.
Knowledge of the use of Computerized Maintenance Management Systems (CMMS) is desired
Previous experience with electromechanical equipment and support systems.
Awareness of the application of maintenance strategies such as vibration analysis, fluid / oil analysis, infrared thermography, and ultrasound
Understanding of process improvement and reliability engineering principles, methodologies, and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA
Acquaintance with cGMPs is a plus
Good communication skills and the ability to perform effectively in multi-disciplinary teams
Prefer knowledge of laboratory and pharmaceutical production and support equipment, including utilities and critical systems (Cell Culture, purification, aseptic filling, packaging, CIP, SIP, HVAC, plant, and clean utilities)
Must be able to lift, push, pull and carry up to 25 lbs.
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
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:
Must be able to work in controlled environments requiring special 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.
Able to work in a cold, wet environment
Must be able to work multiple shifts, including weekends and holidays
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.
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