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Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
Success
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
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Job Description
Summary:
Under the general direction of an associate engineering director, provide engineering support to the Metrology organization for day to day calibration operations, investigations, Metrology quality system elements, and process improvements. Will be a backup for engineering compliance person.
Support the Engineering organization in the selection, troubleshooting, and design of critical instruments, project design reviews, and general instrument troubleshooting and design. Support capital projects as needed. May be assigned other duties.
Essential Duties and Responsibilities:
Prepare technical reports, trend equipment performance data, and resolve identified gaps or adverse trends
Support Metrology Quality System elements (OOTs, KPIs, Training, etc.) under the guidance of Facilities Engineering
Support Metrology Department for internal/external audits, and local/global initiatives by collecting RAM Data, generating reports, etc. as needed
Develop in-depth expertise in the area of electrical and pneumatic instrumentation including the applicable control system interfaces. Participate in project design reviews and approve new instrument applications
Review and approve new instrument RAM requests, criticality assessments, and other related Metrology documentation. Ensure new devices being added to process systems are meeting set standards and are design with the correct critical attributes to meet the intended use of the device. Assess change control requests for new and “like for like” instruments including impact analysis
Gain a full and comprehensive understanding of LA Plant calibration SOPs including, but not limited to, temperature, pressure, conductivity, balances, scales, pH, CL2, ORP, timers, RPM, liquid/gas flow, and gas detection instrumentation
Review and approve out of tolerance (OOT) investigations for Manufacturing and Critical Systems instrumentation
Generate and complete OOT investigations for Metrology standards and calibration device instrumentation
Complete change control, Quality CAPA, and Safety CAPA tasks related to Metrology
Perform other duties as assigned
Qualifications:
Ability to discuss technical or project management issues, both verbally and in written form
Advanced knowledge and application of sound project management skills: planning, organizing, follow-through, and control
Good troubleshooting and problem-solving skills
Basic understanding of control system design, P&IDs, and communication platforms
Ability to quickly and continuously learn new skill sets
Must be able to work independently and make sound judgments regarding work methods and tools
Developing knowledge of the basic principles in various engineering disciplines. Ability to solve routine design and engineering tasks with minor assistance
Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA and other standards engineering units of measurement
Must have good verbal/written communication skills
Good computer skills, knowledge of Microsoft Word, Projects, and Excel
Education and/or experience:
Bachelors’ degree in an Engineering discipline required. 5+ years of related experience
Physical Demands:
Must be able to lift, push, pull and carry up to 25 lbs
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility
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, wet environment
Must be able to work overtime as required
May be required to work in a confined area
Some Clean Room and cool/hot storage conditions
5% travel
This job posting excludes CO applicants.
Check out where you could be
working if you apply.
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Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers.
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