Job Title: Global MES Delivery Specialist
Location: Thousand Oaks/ LA Metro Area
About the role:
- Lead the Global delivery of the Takeda MES solution to the GMS manufacturing network within the U.S.
- Direct small/medium size projects, demonstrate knowledge, require limited direction, handle complex problems, have knowledge of SDLC.
- Gather and document requirements and specifications for medium/large size projects.
- Identify, analyze, propose, and document appropriate solutions for issues that may affect operations.
- Communicate project status. Escalate challenges promptly within the team and throughout the company.
- Maintain relationships within the business or function.
How you will contribute:
- Deliver MES site project (project delivery: project planning – Go-live and hypercare) following MES Project Delivery Model
- Maintain MES site roadmap
- Manage budget and financials for the site projects
- Help develop business benefits for MES deployments.
- Provide global oversight of MES project deployments across manufacturing network.
- Partner with electronic Master Batch Record (MBR) Leads (responsible for designing & authoring the batch record) to use IT tools and best practices for business analysis, library use, and MBR creation.
- Business analysis for process redesign and conversion from paper manufacturing processes to digital
- Partner with vendor and MBR Leads to find alternate ways to use MES out of the box to limit customizations.
- Provide end-user support on applications supported. Mentor/train junior team members.
- Identify, analyze, propose and document appropriate solutions for problems that may improve the project. Identify and understand broader growth. Determine solutions and escalate. Use technical tools (queries, process maps) for problem resolution.
- Manage MES IT for projects in partnership with the MES technical team.
- Work with process/product owners to establish process flow standards in MES
- Identify out of the box functions to implement
- Oversee build-out of process/product templates to be used by multiple manufacturing lines and plants
- Analyze needs for MES customizations versus process workarounds
- Support the MES community of practice across the Takeda operating networks.
- Partner with MES vendors to establish project teams and move projects through lifecycle.
- Link plant level project teams to global level standards for MES Design/Build/Validate/Go Live.
What you bring to Takeda:
- Bachelor's degree or >5 years of experience applying information systems solutions to business problems. Experience in systems testing, validation, problem resolution, and training.
- >5 years of experience in the biotechnology or pharmaceutical industry. Knowledge of plasma, biologics, and small molecule manufacturing.
- Experience with MES or Automation systems. Experience with Werum PAS-X & Siemens Simatic IT eBR is a plus.
- Familiarity with business process flow and entity relationship modeling.
- Knowledge of the systems development life cycle and technology infrastructure.
- Present technical concepts to non-technical personnel.
- Experience with GMP systems and change management process.
- Above average analytical skills
- Can work collaboratively and globally in a dispersed team setting.
- Domestic Travel 25%; International Travel< 1%
Base Salary Range: $87,500 to $125,000. 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 several factors including location, skills, education, and experience.
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
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.
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
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