Engineering Process Validation Specialist II

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Job Description

Takeda's Singapore biologics manufacturing facility focuses on manufacturing potentially life-saving medicines for patients suffering from rare blood disorders such as Hemophilia A and B. As part of the company’s Biologics Operating Unit network, the site is Takeda’s only biologics drug substance manufacturing facility in Asia.  The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda’s first positive energy building certified by Singapore’s Building and Construction Authority’s Green Mark scheme in 2022.

Job Title: Engineering Process Validation Specialist II (SIP)
Location: Woodlands, Singapore

About the role:

• Planning, Performance, Support and Coordination of the following areas: Cleaning Validation, Sterilization In Place, Transport Validation
• Maintain validation status of the above with periodic evaluation, revalidation and change control evaluation.
• Creation of Validation documentation and execution of qualification activities.
• Project support for system/process where validation is impacted.
• Support in process improvement and investigations for system/process where the validation is impacted.
• Adopt current validation practices based on cGMP requirements.
• Support continuous improvement and global standardization for related validation topics.

How you will contribute:

Organization activities

• Serve as a site Subject Matter Expert for at least 1 specialized validation area.
• Independently responsible for organization of Cleaning Validation, Sterilization-in-place and/or Transport Validation.
• Independently scheduling, Organization and coordination of detailed site level validation activities with cross functional groups
• Independently responsible for maintenance of validation (revalidation/periodic evaluation/change control evaluation) for at least 1 specialized area - including scheduling and organization.
• Training of new employees to validation procedures
• Training in accordance of state of the art of science and technology

Documentational activities

• Creation of SOPs or documentation related to the validation activities or maintenance.
• Review and approve of validation protocols, reports, and deliverables for the specialized validation area.
• Define requirements for validation activities and ensure regulatory compliance based on Risk Assessment
• Creation and review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier
• Creation of Protocols and Reports for Validation Maintenance
• Review and check documentation for GMP compliance.
• Collaboration and or Creation of Validation summaries

Engineering

• Definition of relevant equipment investment projects and in creation of User Requirement specifications if required.
• Definition of process relevant validation related parameters of production equipment and product quality parameters for continuous process monitoring
• Troubleshoot and evaluate equipment or system excursions based on validated status or change controls.

Validation Supervision

• Able to carry out validation activities in 2 or more validation areas.
• Report/Review validation activity schedule and planning to validation lead, supervisor or manager on a regular basis.
• Regular preview of pending activities to maintain validation status with validation lead, supervisor or manager.
• Ongoing feedback of validation status to responsible user
• Perform validation activities and/ or support validation activities.
• Ensure validation execution meets compliance, validation standards and cGMP requirements.
• Perform validation documentation and/ or support validation documentation in accordance to the division procedures
• Support data evaluation if necessary.
• Project reporting to central MVP responsible
• Capable of independent feedback and improvement of validation approach based on current best practices and evaluation of constraints.
• Represent site to participate global discussions and contribute to global initiatives.

Internal/External Audits

• Participate in audits.

• Presentation of explanation of validation approach, projects and results

• Support audit response review with timely closure of observations/audit items.

• Planning, Performance, Support and Coordination of Cleaning Validation, Sterilization-in-place and/or Transport Validation.

• Maintain validation status of Cleaning Validation, Sterilization-in-place and/or Transport Validation with periodic evaluation, revalidation and change control evaluation.

• Creation of Validation documentation and execution of qualification activities

• Project support for system/process where validation is impacted.

• Support in process improvement and investigations for system/process where the validation is impacted.

• Adopt current validation practices based on cGMP requirements.

• Support continuous improvement and global standardization for related validation topics.

Others

• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
• Any other duties as assigned by supervisor.

What you bring to Takeda:

Education and Experience Requirements

• Individuals with chemical, biological or comparable technical background; at least 4 years pharmaceutical work experience or 5 years related regulated environment.

• Ideally bachelor degree or higher- in biological/ pharmaceutical sciences or engineering sciences. Equivalent degree or experience possible.

Key Skills and Competencies

• Specialized knowledge of relevant GMP guidelines e.g. EP, USP, FDA

• Logical thinking and meticulous in analysis while being able to assimilate various objectives to the execution of activities.

• Time management and organizational skills for specific projects

• Meticulous and detailed orientated, with a passion for learning and information

• Communication and team work skills

• Passion for learning and knowledge of validation standards

• Able to execute activities in cGMP environment, including cleanrooms or technical areas

• Capable of evaluation of constraints and proposal of validation approach based on Risk based assessments.

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.

Empowering our people to shine:

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, or any other characteristic protected by law.

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