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Job Description
About the role
Based at our Cell Therapy plant in Madrid, reporting directly to Maintenance & Engineering Head, the Engineering Services Manager is responsible for :
- Oversight of the Validation activities at Takeda Madrid Site qualification of equipment, critical systems / utilities, computerized systems, facilities, cleaning and sterilization process qualifications, analytical instrument qualification and transport validation.
- Insurance of the maintenance of state of cGMP validation compliance.
- Engineering compliance with regulations, Takeda policies, quality practices, and proper data and documentation control, including management of technical documents, layouts, manuals and others.
- Represent Takeda Madrid Site during regulatory, corporate, division and third-party inspections; defend the validation program(s) to auditors and inspectors;
support regulatory submission processes.
To lead Process Engineering program, according to global and local requirements for implementation.
How you will contribute :
- Lead, coaching, providing direction and developing the performance of a diverse team of Pharmacists, Engineers and other Life science-related professionals, and develop employees and potential leaders, ensuring high performance, within the Team.
- Represent the main figure / contact of Engineering Services Area with Engineering, Manufacturing, Regulatory Affairs, Quality Validation, Quality Operations, Quality Control, Quality Systems, and other departments.
- Responsible for strategy definition and execution of routine and new project CQVs, covering C&Q of equipment, utilities, facilities and systems, CSV, transport, sterilization and cleaning validation, AIQ, ensuring compliance with FDA, EudraLex, Spanish, and other applicable GMP requirements.
- Harmonization of validation activities with other sites (QMS, Communities of Practice, CoP s).
- Be a validation SME (subject matter expert) for validation and defend validation strategies, topics and documents during internal / external inspections.
- Ensure compliance with regulations, Takeda policies, quality practices, and proper documentation.
- Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs and all aspects of safe, reliable operation of systems.
- Generation and driving of goals, reports, progress metrics, Department Boards to measure performance and Continuous improvement culture.
- Lead for Engineering documentation management and control, EIMS, including technical documents, layouts and diagrams.
- Lead for Process Engineering : Manage the Process Engineering staff, projects and support. Establish engineering discipline and practices that help operate manufacturing while improving process functionality.
- Lead scope definition / clarification exercises to completely characterize process requirements.
- Provide guidance and direction to employees and contractors to meet project and support schedules and financial goals while ensuring technical success.
What you bring to Takeda :
- Minimum of a BS degree in Chemical, Biochemical or Mechanical engineering or equivalent
- Minimum of 5 years of validation experience in writing, completing, and summarizing validation protocols and testing procedures on at least 3 of the next disciplines : CSV, C&Q, AIQ, Cleaning, Transport, Process, Methods or Sterilization.
- Fluent Spanish and English (C1).
Skills and Competencies
Functional
- Analytical skills
- Will break down complex problems and tasks into activities that can be performed by personnel.
Technical
- Broad and in-depth knowledge of current validation approaches, methods, and protocols to evaluate relevant biopharmaceutical / pharmaceutical equipment, systems, facilities and utilities.
- Knowledge on Calibrations
- Knowledge on equipment / systems qualification (HVAC, Cleanrooms, Gas systems, Controlled Temperature Units (CTUs) mapping, and Analytical Equipment qualifications.
- Knowledge of FDA, ICH, EU, PDA, ISPE, ASME(BPE) and other global regulations and GMP guidelines associated with validation requirements
- Experience with / participation in internal / external audits
- Experience with protocol development, deviation identification and resolution, and summary / final report authoring. Experience performing statistical analysis of validation test results.
- Sound industry knowledge and proficiency working in a project environment.
Behavioural / Interpersonal
- Communicate effectively at all levels in verbal and written form, including technical / business writing.
- Team player
- Critical and inquisitive.
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.
