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Job Description

Job Title: IT MES Technical Analyst

Location: Los Angeles, CA

About the role:

As the IT MES Technical Analyst, you will analyze business processes, identify, evaluate, develop, and/or redesign systems and procedures to meet user requirements. You will support Manufacturing Execution System (MES) deployment projects at the Los Angeles facility. You will help troubleshoot MES integrations with other enterprise or local systems and provide consultation to customers on business process redesign. You will lead updates and development of code, system documentation and training materials and training processes. Be a subject matter expert and collaborate with the Global MES team. You will report to the MES Technical Manager.

How you will contribute:

• Manage Assigned tasks, demonstrate solid business and process knowledge, require moderate direction, give minimal guidance to others, handle moderately complex problems, processes and apply knowledge of GXP Computerized System validation.

• Provide business and process knowledge while handling moderately complex problems.

• Follow appropriate software development life cycle (SDLC), standard operating procedures (SOP), quality validation processes, regulatory and quality assurance requirements, and application processes.

• Develop and implement computerized system code modifications to the MES System for project of any size.

• Gather, understand, and document business requirements, including overall objectives and process specifications.

• Align our requirements with software and system capabilities and perform computerized systems code change to meet to provide business partners with requirements and solutions.

• Develop and launch test cases, scripts, and protocols that sufficiently document alignment between code changes and business requirements.

• Collaborate with other teams with building a interfaces to MES and other critical systems.

• Draft and update documentation, such as process functional and design specifications, according to all quality systems and regulatory requirements.

• Collaborate with global and cross departmental teams to help deploy MES at the manufacturing site.

• Identify, analyze, propose, and document appropriate solutions for issues that may impact a project or change.

• Partner and build relationships with departments, global MES team and other global IT teams.

• Participate in Global MES meeting to share site requirements, status, solutions and concerns with the team and across departments.

• Provide end-user level 2 support on application supported by the information technology organization.

• Define and explain business rules required for data accuracy and consistency.

• Provide solid expertise in MES and database interfaces and Coordinate MES related activities at the site, including infrastructure deployment, enabling system integrations, and manufacturing intelligence.

• Experience in FDA regulated industry and familiarity with CFR 21 Part 11, cGMP

• Will apply information systems and process automation solutions to business problems.

• Experience in system implementations, code development, testing, validation, and problem resolution.

• Will work with process automation systems, such as DeltaV and gain knowledge of the software application development process.

• Manage system integrations with MES not limited to JDE, LIMS, DeltaV, and OSI PI.

• Hands-on experience working with Agile development methodology.

What you bring to Takeda:

• High School Diploma or GED plus 6+ years of related experience OR Bachelors' degree preferably in computer science, information systems, manufacturing engineering and 3+ years of related experience.

• Prior IT experience in the Pharmaceutical or Biotechnology industry would be ideal.

• Experience in one or more of the following coding languages such as Python, JAVA, .NET, Visual Basic, C++, and MES.

• Experience with the development of database queries/interfaces (Microsoft SQL, .and Oracle SQL).

• Experience with the functionality of Electronic Batch Management (EBM) to provide technical assistance.

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 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, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

• Will work in a cold and/or wet environment.

• Must be able to work multiple shifts, including weekends.

• May be required to work in a confined area.

• Some Clean Room and cool/hot storage conditions.

• In general, you will have a combination of sedentary work and walking around observing conditions in the facility.

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.

Base Salary Range: $81,900.00 to $117,000.00. Employees may also be eligible for Short-Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors, including, but not limited to, location, skills, education, and experience. 

#GMSGQ #ZR1 #LI-1 #LI-Hybrid

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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