Manager Center of Expertise LVV facility

Leiden Bio Science Park; Netherlands; On-site; EUR 90,000 - 130,000; Full time

Job summary

Leiden Bio Science Park is seeking a CoE Manager to lead the Center of Expertise within the LVV manufacturing facility. You will provide technical leadership on GMP-compliant processes, support single-use equipment, and drive continuous improvements in collaboration with Operations and QA/QC teams.

The role requires extensive experience in GMP production, LEAN project leadership, and strong English communication skills.

Qualifications

• Bachelor or University degree in engineering or science or equivalent technical subject.

Responsibilities

• Lead and direct Manufacturing specialist resources and activities.
• Identify, define and execute base business improvements with Operations.
• Deliver technical requirements for equipment as single-use items and for improvements.
• Support innovations and resolve complex process and technical issues.
• Oversee project execution of small to mid-scale improvements and ensure compliance.

Skills

Leadership

LEAN

Communication

GMP knowledge

English fluency

Education

Bachelor's degree in Engineering or Science

Job description

The CoE is a critical team in the direct support of Operations when it comes to technical process and GMP support. The CoE is key in clear translation of the developed process to aworkable process and environment for the shop floor. The CoE always works against the high quality standards and safety and compliance regulations that are applicable for LVV manufacturing. CoE is responsible for supporting the production teams with specialized and in-depth knowledge and skills on our production processes, GMP, Digital Technology, Materials and Single Use Items. The Centre of Expertise (COE) is a team of around 15 people. The COE team is one of 2 departments within the LVV facility and working with the Operations Department (OPS) which is responsible for the safe, compliant, efficient, and on time production and delivery of the batches (USP, DSP, F&F)

Essential Job Duties and Responsibilities

• The CoE Manager provides leadership and direction for the Manufacturing specialist resources and activities.
• Partners in the LVV facility with Operations in the identification, definition, and execution of base business improvements.
• Delivers technical requirements for the equipment as single use items as well as continuous improvements.
• Encourages and supports the identification and development of innovative solutions to problems and opportunities.
• Oversees technical changes and execution of small to mid complex improvements projects to equipment and disposables.
• Provides comprehensive technical advice.
• Facilitates resolution of complex process & technical problems.
• Promotes innovation initiatives for new processes, products and ideas.
• Reviews and approves technical documentation to verify compliance to technical specifications and standards.
• Communicates with internal and external (OPS, QA, QC, MAM, MSAT, IT) partners to coordinate and execute project plans.
• Assigns tasks according to projected scopes including compliance and quality improvement, cost reduction, cycle time reduction, capacity increase, raw material qualification, and launch preparation.
• Supports implementation of multiple new product development plans and programs for the business unit.
• Monitors smooth execution of plans and programs at lower levels and cross functionally.
• Monitors correct execution of equipment maintenance and repair reports.
• Collaborates with maintenance department to evaluate reoccurring issues that may require equipment replacement.
• Allocates proper level of resources to facilitate attainment of goals within established timelines and budgets.
• Ensures departmental and company compliance with all local government and company regulations, policies and procedures for health, safety and environmental compliance.You will have Beeper duty on rotating basis

Your profile:

• Bachelor or University degree in preferably Engineering or Science or equivalent Technical subjects like Mechanical-, Electrical-, Automation- or Process engineering
• 6-8 years relevant work experience as people leader (Supervisor and/or Manager) with leading and directing teams and/or departments.
• +10 years’ experience in Pharmaceutical (GMP) production environment.
• Tangible experience of successful implemented LEAN projects both on content as leadership
• Fluency in English
• Knowledge of EHSS standards and regulatory requirements in relation to LVV production
• Knowledge of the production process and GMP requirements