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Job Description

About the role:

This position supports site projects, technical transfers, and ongoing validation maintenance. Primarily responsible for compliance during the review of the design, authorship, and execution of commissioning, qualification and/or validation studies for the any or more of the following major disciplines:

• Computerized systems validation (Honeywell, DeltaV, PLC based systems, DHS)

• Facilities, Utilities, and Equipment (FUE) qualification

• Electronic Batch Management (EBM)

• Cleaning validation

• QC Laboratory

• Data Integrity Assessment

This position is responsible to maintain validation documentation aligned with Good Documentation Practices (GDP) and ensure compliance with industry standards (e.g. FDA, EU GMP, ISO, etc)

Provides technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs. Individual must work on moderate to complex assignments, where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables.

How you will contribute:

• Independently review commissioning, qualification and/or validation studies. Partners with SMEs to ensure smooth and efficient execution of testing strategies.

• Provides compliance guidance to engineering for all related commissioning, qualification and validation activities.

• Collaboratively conducts risk and impact assessments.

• Supports development and review of standard operating procedures (SOP) and validation assessments.

• Interfaces with customers on technical issues, project timeline, and validation support.

• Actively participates on cross functional teams to determine the root cause and corrective actions for problems associated with investigations.

• Calculation and interpretation of data for commissioning, qualification and/or validation studies.

• Participates in audits and regulatory agency inspections as a representative of the Quality Validation team, as required.

• Supports development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.

• Provides support for operations and communicates with Program Managers.

• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments.

• Demonstrates continuous improvement with respect to increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, as well as technical understanding/problem solving capability.

• Leads several small projects with complex features.

What you bring to Takeda:

• Requires bachelor's degree in science, engineering or other related technical field. 1+ years of related experience.

• A minimum of 1+ years of relevant experience in a GMP regulated environment.

• At least 1+ years of commissioning, qualification and validation (CQV) desired.

• Validation and/or system experience in the following applicable areas:

• Cleaning validation of manufacturing equipment.

• Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.

• Strong knowledge and experience of automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP. OSI PI.

• Experience with manufacturing operations and biotechnology processes is strongly desired.

• Excellent communication and attention to detail skills.

• Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.

• Ability to be flexible to address both shifting priorities and changes in approach in dynamic work environments.

• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.

• Must be able to solve routine problems with assistance.

• Strong organizational skills, excellent writing and communications skills.

• Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.

Important Considerations:

• Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).

• Must be able to stand for extended periods of time over an entire shift.

• Must be able to climb ladders and stairs while wearing special gowning.

• May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.

• 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. 

• Will work in a cold, wet environment.

• Must be able to work multiple shifts, including holidays and shutdown. Must be able to work overtime as required.

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.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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U.S. Base Salary Range:

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.

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Job Exempt