Maintenance & Engineering Manager
- Permanent, Full-time
Maintenance & Engineering Manager
- 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
- 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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- At least 5 years experience
- 14 August
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