Engineering Services Manager

hace 2 semanas

Madrid, España Takeda Pharmaceutical A tiempo completo

**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).
- 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
- 10 years hands-on validation, engineering, and technical experience in a biopharmaceutical pharmaceutical production environment.
- 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

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