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Job Description

About the Role:

This position will provide guidance in validation strategy to the site and global projects. The position will have engineering validation signatory responsibility for approval of cleaning cycle development and cleaning validation protocols and final report documents. This position is responsible for assessing and validating cleaning processes.

Primary tasks include development of protocols, coordination of validation activities, execution, preparing final reports and assembly of final validation packages; generation of project plans. Responsibilities will consist of both initial validation efforts as well as revalidation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented. Final documents are archived and may be included in or support regulatory submissions, and made available as needed during internal and external regulatory/compliance audits. This position will provide interpretation of regulatory requirements.

This position will work in close cooperation with the manufacturing business units, Engineering, Regulatory, QC, and Quality Operations on a day-to-day basis.

How you will Contribute:

• Applies thorough understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training as appropriate.

• Performs a variety of projects/studies in several areas at the same time to support manufacturing and engineering.

• Handles projects that are more complex and broad in scope, which require team leadership and task prioritization. Must demonstrate competent and effective planning, coordination, and organizational skills.

• Review and asses change control requests with potential impact to validated state of validation elements, as applicable.

• Handles routine tasks with attention to detail, timely and accurately.

• Participate and interface with cross-functional project team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle: user requirements, functional specifications, design specifications, cycle development and validation. Emphasis is on ensuring accuracy and integrity on validation documentation meets regulatory guidelines and industry standards.

• Write protocols and reports, execute, interpret, and evaluate validation documents in terms of acceptability to industry standards (GMPs, FDA, EU and JP Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1, USP-NF, etc.).

• Guide peers in Validation and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses and interpretation of test results.

• Utilize Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA, Design of Experiments, QbD, SPC).

• Must be able to identify opportunities for optimization processes within the department or the site.

• Identify gaps related to validation requirements and Global Validation procedures. May drive and close compliance gaps as they are identified.

• Perform updates to element validation assessments and validation plans, as required.

• Assist / support, as required, in the investigation and closure of non-conformances/events, corrective actions and preventative actions.

• May participate in the generation and updating of standard operating procedures based on operations and validations to meet divisional and regulatory requirements.

• Participate in internal and/or external assessments and/or audits, as required. Support process with timely closure of observations/audit items.

• Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors. Present validation strategy and protocols in regulatory inspections.

• Participate and support in Global Validation initiatives for harmonization and streamlining efforts.

• Perform other duties as directed by supervisor.

What you bring to Takeda:

• Bachelor's degree in engineering discipline required. Chemical, Mechanical, Electrical Engineering Degree Preferred. 2+ years of related experience.

• Minimum 2+ years validation experience.

• Experience in manufacturing processes and cleaning processes are required.

• Must have experience and proficiency in pharmaceutical/biotech validation elements, as applicable, including the writing and executing of protocols and standard operating procedures.

• Must have a strong comprehension of the operating principles in a cGMP regulated environment. Hands-on Manufacturing, Engineering and/or Technical Service experience is a plus.

• Must be able to work independently and as part of a team. Must also have demonstrated ability to produce results in a cross-functional team environment (including technical and non-technical work) with minimal supervision.

• Must demonstrate leadership skills.

• Must possess excellent technical writing, communication, and organizational skills.

• Must display a solid technical understanding of Quality Engineering of the validation element principles and procedures and scheduling a series of project technical and project management overviews without assistance.

• Must be proficient with Microsoft Office including MS Word, Excel, Power Point, Visio and Project.

• Must have the ability to prioritize multiple projects and manage time efficiently in order to meet established timelines.

• Ability to communicate effectively at all levels in verbal (soft skills) and written form, including technical/business writing.

• Must be able to identify opportunities for optimization of processes within the department or the site.

• Should have experience in problem analysis and resolution

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:

• May be able to lift, push, pull and carry up to 25 lbs.

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

• Will work mostly in office environment with requirements to work in manufacturing and support areas.

• Will 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.

• May work in a hot/cold, wet environment and climb up into large processing tanks.

• Will work in Cleanrooms, including cold/hot storage conditions.

• Must have the ability to work in confined spaces (e.g. attic space, engine rooms and tanks).

• May work in a loud area that requires hearing protection and other protective equipment to be worn.

• Will work around chemicals, such as alcohol, acids, buffers, and celite, that may require respiratory protection.

• Must be able to work multiple shifts, including weekends and extended hours, as required.

• 5% travel may be required to other Takeda facilities in order to manage projects related to these facilities or interact with other validation colleagues and/or as part of professional development.

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.

#GMSGQ #ZR1 #LI-Onsite

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