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Romark

Maintenance & Engineering Manager

Published on Jobat.be 19 days ago

Maintenance & Engineering Manager

Job description

  • Provides technical leadership and direction for process engineering, packaging engineering and validation functions. 
  • Ensures full alignment of the Maintenance & Engineering team with the organization’s objectives, goals, and compliance metrics.
  • Provides support in matters such as investigations, manufacturing equipment reliability, process improvement projects, product customer complaints and support to audits and inspections.
  • Responsible for all Commissioning and Qualification (C&Q) activities for facilities, equipment and utilities.
  • Responsible for periodic review of  Manufacturing Equipment and management of change as relates to qualified/validated state.
  • Manages department’s budget, including cost control and spending prioritization to meet organization’s objectives.
  • Understands corporate business plan and sets goals for the Maintenance and Engineering Department to ensure that plans goals are met; clearly communicates goals to the department’s staff, and initiates tools to measure the success of the department.
  • Collaborates with strategic planning by studying technological and financial opportunities; presenting assumptions; recommending objectives
  • Daily supervision of the department’s personnel
  • Collaborates in keeping compliance with state and federal regulations
  • Assure that all procedures are follow and all regulatory are met.  Assure regulatory inspections are met   
  • Keeps equipment operational by coordinating maintenance and repair services and calibrations, following manufacturer instructions
  • Manage all outside service contracts, such as landscaping, housekeeping, pest control, security, utility support providers, etc.
  • Assure that all ground, facilities and equipment are in the best maintenance and repair and that the pest control program is an effective one.
  • Anticipates operational problems by studying operating targets, modes of operation, unit limitations; monitoring unit performance
  • Prioritizes resources to drive flawless execution of process equipment, facilities, and utilities
  • Serves as the single point of contact for site matters related to the scope of Engineering Services
  • Identifies innovative solutions for enhancement of site facilities, utilities, and process equipment
  • Keeps up with current trends and regulations within the pharmaceutical industry

Profile

  • Master’s Degree in an Engineering, Pharmacy or Science Discipline is required 
  • Minimum of 10 years of experience in a GMP product manufacturing plant environment within the pharmaceutical industry
    • product/process development of pharmaceutical products, manufacturing of pharmaceutical products, R&D, Technical Services, Engineering in pharmaceutical field.
    • Must have strong knowledge and application of FDA and ICH regulatory requirements and latest guidance in the development, validation, and manufacture of pharmaceutical products and qualification of manufacturing equipment 
  • Ability to plan and implement complex project requirements
  • Full knowledge of management principles; project management
  • Solid knowledge of the cGMPs and FDA Guidelines
  • Must have knowledge of Quality Systems (CAPA, change control, etc.)
  • Basic financial and budgeting management experience is required
  • Strong strategic planning and tactical execution abilities, including strong organization skills is required.
  • Ability to take initiative regarding innovative approaches to problem solving in a fast-paced, changing business environment is required
  • Process Excellence and Lean experience  
  • Proficiency with Microsoft (Word, Excel, PowerPoint, etc.)
  • Strong verbal and written communications skills (in both Dutch and English) for multi-level stakeholders, including the ability to negotiate win-win solutions to drive standardization are required
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Romark | Roosveld 6, 3400 Landen

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    41 days left to apply

    Characteristics

    Requirements

    • At least 5 years experience

    Offer

    • Permanent
    • Full-time

    Apply before

    • 14 August

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