Engineering Validation Specialist ( CSV)
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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 Validation Specialist (CSV)
Location: Woodlands, Singapore
About the role:
- Planning, Performance, Support and Coordination of Computer System Validation
- Maintain validation status of Computer System Validation
- Creation of Validation documentation and execution of qualification activities
- Project support for system/equipment where validation is impacted.
- Support in process improvement and investigations for system/equipment where the validation is impacted.
- Adopt current validation practices based on cGMP requirements.
How you will contribute:
Organization activities
Primarily responsible for leading and supporting all computer validation aspects to the automation and engineering teams of Takeda. This includes Domain Controller system (DCS), Manufacturing Execution system (MES), Manufacturing data warehouse (MDW), Building Automation Systems (BAS), GMP and non-GMP, Programmable Logic Controllers (PLC) based skids, IT infrastructure, standalone computerized system with equipment and validated spreadsheet.
Works with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.
With good fundamental technical knowledge of automation systems such as Siemens PCS7 , OSIPI or IT system to assist automation engineers in developing life cycle documentation.
Independently schedule, organize and coordinate at detailed site level, validation activities with cross functional groups.
Independently responsible for maintenance of validation (revalidation/periodic evaluation/change control evaluation) for the area of computer system validation - including scheduling and organization.
Training of new employees to validation procedures.
Training in accordance with state of the art of science and technology.
Documentational activities
Assist in raising Change Control to update Automation System Life cycle documentation, SOPs, Risk Assessment, Requirement Traceability Matrix etc.
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/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) 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 computer system investment projects and in creation of User Requirement specifications if required.
Troubleshoot and evaluate equipment or system excursions based on validated status or change controls
Validation
In addition to computer system validation, ability to carry out validation activities at least one additional validation areas, e.g. Equipment Qualification, Sterilization In Place, Temperature Controlled Objects (Freezers, Incubator etc), Cleanroom Validation, Clean Utilities Validation (IQ/OQ/PQ/CPV), Cleaning Validation or Process Validation.
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.
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.
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’s degree or higher- in biological/ pharmaceutical sciences or engineering sciences. Equivalent degree or experience possible.
Knowledgeable in GAMP5, ANSI/ISA-88 and 21 CFR PART 11 requirements.
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.
Ability to work on complex problems which requires in-depth analysis and evaluation of situations and/or data and provide proposals on path forward within the working team.
Accurate interpretation of global policies and exercise judgement for broadly defined standards for evaluation criteria and bring complex decisions with proposals for endorsement to higher management, if required.
Manage and collaborate with internal stakeholders to ensure Validation compliance, and business continuity.
Capable of managing any external contract validation resources to ensure successful project completion, e.g. coaching for test protocol development and updating life cycle documentation per Takeda’s requirements.
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.
