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Lead facility & Equipment improvements by providing engineering expertise and project management for the maintenance and upgrade of infrastructure and systems that support compounding operations.
Job Responsibility:
Lead facility & Equipment improvements by providing engineering expertise and project management for the maintenance and upgrade of infrastructure and systems that support compounding operations
Manage, arrange, and supervise equipment maintenance and upgrade efforts to ensure equipment availability, reliability, and capability are steadily enhanced
Develop and put into practice preventative maintenance procedures and schedules that guarantee equipment availability, reliability, and product quality, in accordance with our business strategy and site requirements
Coordinate equipment and facility maintenance requirements with Quality and Operations to ensure compliance and minimize disruption to production schedules
Manage the contractor relationship for production support systems such as CPM and EMS
Apply the engineering upgrade plan for the Compounding Unit, concentrating significantly on reliability
Coordinate and manage the installation, testing, operation, maintenance, and repair of all facilities and equipment within the Compounding Unit
Develop and carry out preventative maintenance procedures and schedules that ensure equipment availability, reliability, and product quality in accordance with the Compounding Engineering Strategy and Baxter Perfect Equipment requirements
Direct and coordinate engineering activities associated with all Compounding units and equipment, managing contractors, service providers, installation engineers, etc
Manage and guide engineering projects connected to the Compounding Unit to guarantee timely and budget-conscious completion
Lead and support compounding capital, continuous improvement, and automation projects such as BAXA Repeater Pumps, working closely with SAN Project specialists and Unit Managers where required
Ensure planned, preventative, and reactive maintenance is performed per system requirements and on time
Support the procurement team as subject matter experts for facility systems (HVAC, Coldrooms, FMS etc.) in contract renewal and negotiations
Manage the relationship with outsourced vendors providing critical maintenance, calibration, and service contractors
Support and troubleshoot maintenance issues and system failures
Manage and support GMP documentation to complete validations and change controls for facility projects
Partner with local site EHS to ensure maintenance processes and capital projects are accomplished in compliance with applicable regulations
Identify and manage critical spares inventory for the Unit and liaise with other Compounding Units for parts sharing initiatives.
Requirements:
A solid amount of experience in maintaining electrical and mechanical plant and equipment
Experience in setting up new plant and equipment
Strong interpersonal skills and proficiency in conveying ideas
Responsive and flexible attitude to supporting internal and external customer requirements
Experience working in a support role with a strong emphasis on reliability
Rapid appreciation of issues, sound judgement, and problem-solving skills
Capacity to perform well when facing tight deadlines and remain effective while collaborating within a committed group
Flexibility to cover some weekend work or out-of-hour maintenance when required
At least 3 years' experience in efficient equipment upkeep and maintenance planning within the Pharmaceutical / Medical Device sector
Degree or equivalent experience in Science or a related field
Demonstrated experience in a GDP/GMP setting, ideally with at least 2-3 years of background
Experience in dealing with regulatory compliance is desired
Practical Problem Solving
Project Management experience desired
Risk Assessment
Negotiation skills
Respond well to time constraints
Good professional standards and demonstrates good attention to detail
Capability to perform effectively under pressure and achieve deadlines
Highly motivated self-starter and team worker
Ability to collaborate within a group setting and handle a broad variety of distinct tasks
Strong organisational, coordination and communication abilities
Ability to handle a wide variety of specific tasks
Excellent organisational and coordination skills
Ability to work in a dynamic, fast-paced, and achievement-focused environment. Be determined.
Nice to have:
Project Management experience desired
Experience in dealing with regulatory compliance is desired.