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Metrology Compliance Lead

Takeda Pharmaceuticals International GmbH

This is a Full-time position in Los Angeles, CA posted March 30, 2021.

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), we’re leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you.

*Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info.

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.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

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.

Job Seekers: Protect yourself against identity theft

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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