Continuous Improvement Manager, New build

Wärtsilä Corporation; Aldaya; Presencial; EUR 45.000 - 90.000; Jornada completa

Descripción de la vacante

Una empresa innovadora busca un líder en tecnología y transferencia global para impulsar la competitividad de los procesos de fabricación. Este rol clave implica la gestión de proyectos de transferencia tecnológica y optimización de procesos, garantizando la calidad y el cumplimiento de estándares cGMP. El candidato ideal tendrá una sólida experiencia en la industria farmacéutica, habilidades de gestión de proyectos y una comprensión profunda de los procesos de fabricación de sustancias. Si tienes pasión por la mejora continua y deseas impactar en la salud global, esta es tu oportunidad.

Formación

• Mínimo 10 años de experiencia en la industria farmacéutica.
• Experiencia en proyectos de transferencia de tecnología en entornos altamente regulados.

Responsabilidades

• Gestionar proyectos de optimización de procesos y transferencias tecnológicas.
• Colaborar con equipos de mejora continua para mejoras de productos/procesos.

Conocimientos

Gestión de Proyectos

Conocimiento de GMP

Comunicación

Trabajo en entornos multiculturales

Conocimiento de procesos de fabricación de sustancias farmacéuticas

Conocimiento de procesos de fermentación

Educación

Licenciatura en Ciencias (química, biotecnología, farmacia, ingeniería)

Descripción del empleo

Descripción del trabajo

Centrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms.

We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines.

With our commitment to Quality, Reliability and Sustainability at the heart of everything we do, our over 2200 employees work continuously to meet our customers’ needs. We work towards a sustainable future by actively participating in the fight against antimicrobial resistance.

Founded 150 years ago as the ‘Nederlandsche Gist- en Spiritusfabriek’, our company was known as Gist Brocades. Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, the United States and Mexico. Centrient Pharmaceuticals is wholly owned by Bain Capital Private Equity, a leading global private investment firm.

The Position

The Global Technology and Transfer Lead drives competitiveness of Centrient manufacturing processes via standardization, technology improvement projects and assists the sites when trouble shooting. Is responsible for flawless execution of tech transfers activities in line with cGMP and SHE standards when introducing new or improved processes developed by Innovation to commercial manufacturing sites. As a global expert realizes EBITDA growth and improved reliability by introducing new and / or improved products and processes.

The main activities and responsibilities

Owns the process knowledge of the product(s) assigned and throughout the commercial lifecycle maintains the oversight on process capability :

Transfers :

1. Review Technology Development Reports prior to transfer and validation, adapt control strategy if needed.
2. Define scale-up, pre-validation / validation strategy.
3. Ensure that all relevant technical information and documentation for validation is available.
4. Support Site MS&T and Validation Lead / Validation Expert in creation of relevant product documentation (i.e. validation protocol and report).
5. Review first APQR after transfer to ensure adequate product performance.
6. Manage transfer projects.

Improvement / Major changes :

1. Manage process optimization projects.
2. Assess impact of major changes, assess their technical feasibility, challenge technical risk and business benefit of technical changes proposed.

Manufacturing Excellence :

1. Provide SME expertise to increase robustness and sustainability.
2. Collaborate with Continuous Improvement teams for product / process improvements.
3. Support trouble shooting activities.
4. Participation in due diligence.
5. Development of local teams.

Requirements

The Ideal Candidate

1. University degree in Science (chemistry, biotechnology, pharmacy, engineering) or other related studies.
2. At least 10 years’ experience in pharmaceutical industry.
3. Fluent proficiency in English language (written and spoken).
4. Experience in Technology Transfer project at highly regulated environments.
5. GMP and Compliance knowledge at pharma industry and high regulated environment.
6. Good understanding / experience of drug substance manufacturing processes.
7. Experience in fermentation processes.
8. Project Management skills.
9. Good communication skills.
10. Experience to work on multicultural environments.

Terms and reward

We offer a local contract in a challenging, comprehensive, operational environment, with many opportunities for personal input and growth and plenty of discussions with other professionals. The organization is very flat. You have a lot of freedom and responsibility in an open, direct, and informal atmosphere.

The Procedure

Please submit your application via the 'apply' button and upload your CV & cover letter in English. We also ask you to include information on your current remuneration. Only applications with CV and Cover Letter will be considered.

For more detailed information about the role and about the Recruitment & Selection process you can contact us via (emailprotected). We invite you to visit our website for information about our company.

Reference check procedures are part of the Centrient Recruitment & Selection Process. You will be contacted when a reference check is required.