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Job Description

About the role:

Primary Duties

• Improving the reliability of equipment, critical systems and maintenance processes by applying the principles of Reliability Engineering program.

• Apply Root Cause Analysis methodologies to improve equipment that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. Measure reliability performance and demonstrate success of improvements.

• Lead reliability driven actions that require independent and/or collaborative judgment.

• Support capital projects as needed.

• May be assigned other duties.

Responsibilities

Maintenance Strategy:

• Determine the Equipment Importance Level for Equipment/System.

• Determine maintenance strategies based on

• Equipment/System importance level for new and existing equipment/System.

• Develop maintenance plans for new and existing equipment/systems.

• Responsible for the technical content of preventive maintenance SOPs.

• Responsible for the effectiveness of the maintenance programs, ensure accurate work instructions

Preventive maintenance optimization:

• Identify opportunities for improvements in maintenance programs and implement appropriate changes to the maintenance strategy for equipment.

• Own the equipment maintenance improvement initiatives.

• Evaluate requests for PM extensions, provide technical justification and approve if justified.

Equipment Prioritization and Predictive maintenance program management:

• Identify Worst Performers (“Bad Actors” and “Waste Producers”).

• Determine the appropriate Hierarchy for Equipment/System.

• Define strategies and methodologies to prevent functional failures, also detecting the onset of functional failures in their earliest stages.

• Responsible for the implementation of predictive maintenance across the facility.

Failure Analysis and CAPAs:

• Lead and/or participate in Root Cause Analysis Teams.

• Perform analysis of failures applying appropriate analysis techniques (data analysis techniques, FTA, RCA, RCFA), in order to identify and eliminate the causes of functional failures.

• Inspect and analyse damaged parts detected during maintenance activities.

• Own the equipment reliability related relevant CAPAs.

• Respond to audit findings that are equipment maintenance relevant.

• Collaborate and provide support to engineering organizations and to production.

• Identify and communicate opportunities for operating and design improvements. Collaborate to develop engineering solutions.

Spare parts management; CMMS; Metrics:

• Responsible for accurate content of equipment master data within CMMS

• Define the content of the equipment spare parts list (EPL), BOMs, and stock level. Responsible for their accurate, complete and updated content.

• Perform functional equivalency assessment for spare parts.

• Participate in the development and evaluation of technical suppliers and/or providers of maintenance services.

Equipment performance, Data Analysis and Trends:

• Own the monitoring concepts.

• Report key performance metrics for equipment/systems.

• Monitor and analyze data and trends for equipment that are of most importance to the business.

• Report the progress and effectiveness of Reliability Engineering Improvement initiatives.

Training and Documentation:

• Apply and teach Reliability concepts. Provide necessary training and skill refinement to technicians and operators.

• Collaborate to develop appropriate and complete troubleshooting for equipment/system issues.

• With Site Engineering, ensure availability of OEM manuals, vendor drawings, vendor literature.

What you bring to Takeda:

Education and Experience Requirements

• Critical / Key skills:

• Knowledge of a GMP environment

• Operational maintenance methods

Language & IT Skills

• English speaking & writing

• Knowledge on CMMS system (JDE, SAP..)

Key Skills, Abilities, and Competencies

• Based on fact and datas

• Methods oriented

• Analytics

Complexity and Problem Solving

• Responsible of Maintenance Plan for all process equipment.

• Reliability assessment can goes to Small Project.

Internal and External Contacts

• Internal buyer (ex: spare part order and receipt..)

• External Supplier (ex: offer asking for spare-parts..)

• Internal Engineering, Manufacturing, Project manager

Other Job Requirements

• Travel can be an option

• Home office working is acceptable but not on a full time basis

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.

Empowering our people to shine:

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, or any other characteristic protected by law.

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