Senior Manager Engineering Validation Maintenance

Job description

Janssen Vaccines & Prevention B.V. is a global biotech company which is part of the Johnson & Johnson family of companies. Within this family the company focuses on the development, production and marketing of vaccines to prevent and combat infectious diseases. At the Leiden Site, talented and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to the company.

For our Engineering, Validation & Maintenance (EVM) department we are currently seeking a fulltime;

Senior Manager Engineering, Validation and Maintenance (m/f)

Jansen Vaccines and Prevention (JVP) are looking to recruit a Senior Manager for the Engineering, Validation and Maintenance group for a two year secondment. This group is responsible for onsite Engineering services, support to laboratory, cGMP pilot plant and technical infrastructure in the JVP organization. The group consist of approximately 30 FTE (including contractors) split over the functional disciplines Project engineering, Validation and Maintenance of equipment, building and utilities.

Purpose of the Job:

The senior manager EVM plans and directs overall engineering maintenance and validation activities for the Janssen Vaccines site in Leiden. Principal tasks are:

· Manages EVM department and budget in a compliant and responsible manner consistent with JnJ standards and our credo values.
· Coordinates the creation, development, design and improvement of the technical systems on site in conformance with established programs and objectives aligned with business needs.
· Ensures business continuity with active programs to address short and long-term business needs with respect to equipment, utilities and installations (e.g. replacement strategy).
· Provides engineering maintenance and validation advice and assistance to other departments as required including technical project management (management, execution and budget control) of engineering related Capex investments.
· Connects and initiates value adding relationships with peers across campuses and on corporate level.

Reporting lines:

Senior manager EVM reports to Senior Director Drug Substance development (DSD), a member of the VPAD Leadership team. In this role you will be part of the DSD leadership team as well as functional representative of EVM group in relevant governance forms. You will steer a multidisciplinary group of Supervisors and leads as well as staff engineers from Jr. engineer level (PG23) till Sr. engineer level (PG 30)

Desired profile

Qualifications :

Requirements

·  The minimum education required for the position is a Bachelor Degree in technical discipline like Mechanical, Electrical, Automation or equivalent.
·  The minimum level of experience required for the position is 4-8 years as Supervisor or 2-4 years as Manager
·  You will be expected to have had proven experience in regulatory requirements and industry guidelines specific for the pharmaceutical industry and Validation (e.g. FDA, GMP, ICH, ASTM, ISPE, etc.) as well as principle of cGMP.