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Job Description

About the role:

Support the risk-based asset management program lead by the Reliability Engineering team.

Responsible for improving the reliability and lowering maintenance costs of CUB equipment by applying the principles of Reliability Centered Maintenance (RCM). Apply Root Cause Analysis (RCA) and Failure Analysis (FA) methodologies to investigate equipment failures and to identify potential corrective actions to prevent failures reoccurrence.

How you will contribute:

• Participate in the development of maintenance strategies, plans, parts lists, BOMs and frequencies for new and modified equipment.
• In collaboration with safety, quality, and manufacturing perform equipment importance level assessments.
• 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.
• Report CUB equipment performance RE metrics (i.e., Bad actors, MTBF).
• Support functional equivalency assessments of spare parts.
• In collaboration with engineering, manufacturing, and maintenance personnel perform or support troubleshooting of equipment.
• Participate in Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA).
• Support Reliability Centered Maintenance (RCM) improvement projects in assigned area.
• Provide support for audits.
• Identify and implement potential PM optimization opportunities.
• Identify cost/waste/energy reduction opportunities.
• Support the implementation of predictive maintenance technologies to increase equipment uptime.
• Collect relevant data and perform predictive maintenance analysis in one or more of the following technologies: vibration collection, dynamic balancing, oil/fluid maintenance, ultrasonic analysis, infrared thermography, motor circuit analysis (MCA), online/vibration monitoring, when required.
• Assist in the development of PdM systems and procedures to ensure accurate and repeatable data is collected and analyzed on targeted equipment at appropriate intervals.
• May be assigned change control, Quality CAPA and Safety CAPA tasks.
• May perform other duties as assigned.

• Familiarity with GMP is a plus.
• Have advanced electrical and mechanical knowledge with respect to systems including but not limited to utility systems and pharmaceutical processing equipment.
• Have advanced knowledge of hygienic and non-hygienic pumping systems, fans, heat exchangers, air compressors, agitators, A/C & DC motors, VFD’s, pressure vessels, piping systems, valves, and control systems.
• Have proficient computer skills (BAS, SCADA, Electronic Mail, Intranet) and be experienced using MS Office software (Word, Excel, and PowerPoint).
• Have basic knowledge of NFPA 70E electrical standards.
• Proficient in reading P&ID’s, equipment manuals, and specifications.
• Possess or have ability to gain knowledge of FDA, OSHA, EH&S, EPA, and state of Georgia requirements.
• Familiarity with Change Control, Site, and Divisional SOPs related to position and department are required.
• Familiarity with NDT technologies and their associated applications.
• Have very strong verbal and written communication skills, and good documentation practices (cGDPs).

What you bring to Takeda:

Education and/or experience:

• Associates Degree in Engineering or Engineering technology desired but not required
• Preferred 10 years combination of education, training, and experience in a cGMP related environment.

Physical Demands:

• Must be able to lift, push, pull and carry up to 50 lbs.
• In general, your work will be a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

• Will work in controlled environments requiring special gowning. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work in a cold, wet environment.
• May be asked to work in a confined area.
• Must be able to work multiple shifts, including weekends.
• Must be able to work overtime as required (only for non-exempt positions).

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
• Tuition reimbursement

Important Considerations

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:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

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EEO Statement

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.

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