Engineering Services Manager - Madrid, España - Takeda Pharmaceutical

Takeda Pharmaceutical

Empresa verificada

Madrid, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

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 thirdparty 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 sciencerelated 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 qualityrelated 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 handson 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 indepth 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