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 Lead
Location: Woodlands, Singapore
About the role:
- Lead planning, performance, support and coordination of the following validation areas: Cleaning Validation, Sterilization In Place, Transport Validation
- Supervise the Engineering Process Validation team with Subject Matter Experts (SMEs) comprising of Snr Engineers/Engineers for the validations at suite 1 and suite 2.
- Act as a plant representative for the Engineering Process Validation group interfacing with Global Validation Systems of the above validation area.
- Report to Engineering Services Manager to ensure compliance to cGMPs and division validation standards.
- Accountable for fulfillment of internal and external guidelines in these validation area
- Define, plan, monitor and review the provision of personal resources for Validation/Qualification projects.
- Define, plan, monitor and review the timely execution of revalidation, periodic evaluation to maintain the validated status.
- Responsible for the evaluation of validation approaches and lifecycle maintenance
- Definition of validation lifecycle programs within the sit
- Responsible of training requirements and responsible for training of dedicated employees
- Responsible for creation and release of area specific quality relevant validation documents (SOPs, Forms, protocols, and reports)
- Representation and responsible as Subject Matter Expert (SME) for Validation team during audits (internal and external)
- Driving process improvement and investigations for system/equipment where the validation is impacted.
- Adopt best in class validation practices based on cGMP requirements.
- Driving continuous improvement and global standardization for related validation topics
How you will contribute:
Organization activities
- Organizational responsibility and coordination of Validation group
- Supervisor and leader of dedicated employees
- Interface position between Validation and all other manufacturing and Quality units
- Responsible for providing personal resources for Validation/ Qualification
- Responsible for periodic reporting to local management
- Maintenance of Validation/Qualification lifecycle system
- Responsible for maintenance process of Validation objects (scheduling and planning)
- Maintenance of training status of Validation employees
- Responsible for process improvements in Validation group
- Responsible for realization of Performance Management Process and site-wide monitoring programs
Documentational activities
- Review and approve of validation protocols, reports, change controls and deliverables.
- Responsible for maintaining all documents and SOPs which are in the responsibility of Validation group.
- Creation and Review of Validation documentation (URS, Risk Assessments, Validation protocols and
- Validation reports) in accordance with the Master Validation Plan / Divisional Procedures for Singapore site
- Check Validation/ Qualification documentation functional propriety.
- Collaboration in and/ or Creation of Validation summaries
Engineering
- 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
- Independent Planning and Organization of employees for Engineering Process Validation in accordance to Management requirements
- Regular preview of pending activities to maintain validation status.
- Scheduling of projects
- Ongoing feedback of validation status to Management
- Personal organization of the Engineering Process Validation group
- Management of dedicated staff and development of Engineering Process Validation team
- Able to represent site Validation group for discussions and contribute to division initiatives.
- Forecasting of requirements and workload balance for Engineering Process Validation team, highlighting and resolving critical deficiencies to management
- Analysis of validation deficiencies and gaps
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 6 years pharmaceutical work experience or related regulated environment
- At least 2 years of supervisory experience and leadership experience
- Ideally bachelor’s degree or higher- in biological/ pharmaceutical sciences or engineering sciences. Equivalent degree or experience possible.
- At least 5 years of Validation/ Qualification experience preferably in pharmaceutical industry.
Key Skills and Competencies
- Specialized knowledge of relevant GMP guidelines e.g. EP, USP, FDA
- Logical thinking and meticulous analysis while being able to assimilate various objectives to the execution of activities.
- Effective time management and organizational skills for specific projects
- Meticulous and detailed orientated, with a passion for learning and information
- Effective communication and teamwork skills
- Team leadership and supervision skills are essential.
- Personal integrity and dedication toward objectives
- Passion for learning and knowledge of validation standards
- Capable of evaluation of constraints and proposal of validation approach based on risk-based assessments.
- Ability to motivate direct reports and work in a matrix environment.
- Able to take independent strategic decisions.
- Opinion leader at site and global level
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.
