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Job Description

Job Title: IT MES Technical Analyst

Location: Los Angeles, CA

About the role:

Analyze business processes and evaluate systems to meet user requirements. Support MES (Manufacturing Execution System) deployment projects at the Los Angeles facility. Help troubleshoot MES integrations with other enterprise and local systems. Provide consultation to customers on business process redesign. Lead updates and development of system documentation and training materials and training processes. Be the subject matter expert and collaborate with the Global MES team to ensure understanding.

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. Other responsibilities include:

• Understand appropriate SDLC, SOP's, 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 requirements and process specifications.
• Align requirements with software and system capabilities and provide partners with solutions
• Perform computerized systems code change to meet requirements.
• Develop test cases, scripts, and protocols that sufficiently document alignment between code changes and requirements.
• Collaborate with other teams with building interfaces to MES and other important systems.
• Draft and update documentation, such as process functional and design specifications, according to all quality systems and regulatory requirements.

Minimum Requirements/Qualifications:

• High School Diploma or GED plus 6+ years of related experience OR Bachelors' degree in computer science, information systems or other related technical field; 5+ years experience in the Pharmaceutical or Biotechnology industry
• Bachelor's degree or equivalent experience preferably in manufacturing, engineering or computer science
• Experience in FDA regulated industry and familiarity with CFR 21 Part 11, cGMP
• Experience applying information systems and process automation solutions to business problems.
• Experience in system implementations, code development, testing, validation, and problem resolution.
• Help deploy MES at the manufacturing site by collaborating with all teams (direct or indirect)
• Identify, analyze, propose, and document appropriate solutions for issues that may affect a project or change.
• Identify and understand issues that may affect the project scope and timelines.
• Communicate status, solutions, and concerns. Communicate information promptly within the team and throughout the company.
• Establish relationships with partners, global MES team, and other global IT teams (LIMS, JDE, Track Wise).
• Participate in Global MES meeting to ensure the LA site requirements and issues are communicated and represented.
• Coordinate MES related activities at the site, including infrastructure deployment, ensuring system integrations, and manufacturing competencies.
• 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 knowledge in MES and database interfaces.
• Solid knowledge of the software application development process
• Experience with Manufacturing Execution System (MES) and manufacturing intelligence tools, such as OSI PI
• Experience working with process automation systems, such as DeltaV
• Expertise with the development of database queries/interfaces (Microsoft SQL and Oracle SQL)
• Background in Visual Basic programming
• Technical knowledge and requirements to one with a non-technical background.
• Team player and works well in a collaborative environment

Physical Demands:

• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment:

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, 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.

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.

Absent an approved religious or medical reason, all US field-based employees must be fully vaccinated for COVID-19, as a condition of employment.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range: $ 79,800 to $ 114,000. 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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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.

Locations

USA - CA - Los Angeles

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time