Engineer - Compliance - Pharmaceutical - CMMS
A qualified degree level engineer with strong post qualification experience in the pharmaceutical industry. Skill set can be either Mechanical or Chemical. The engineer will be responsible for planning, compliance within engineering, change management, data trending PAI issues and must have good GMP and FDA experience. There will be the introduction of a new CMMS system so you will work with this for successful implementation The company will be working towards an FDA inspection and therefore all systems must be compliant and have full integrity. Experience of IMS and CMMS (possibly Maximo) and preferably Autocad. You will oversee Engineering electronic and documentation systems to provide technical assistance to any sites which manufacture products. Leading Continuous Improvement activities within the department and be accountable for ensuring that all quality led documentation is managed in the correct time and to the required timeline. This is a key position within the Engineering Department requiring planning, engineering and documentation skills appropriate to a pharmaceutical or highly controlled environment. Whilst expected to work closely with the rest of the Engineering team, engineering support will need to be provided for the site; across a range of departments. The job holder has responsibility for maintaining cGxP and H&S knowledge applicable to the job. Quality is a primary focus to ensure that patients receive a Safe, effective and quality assured product. This requires working to the principles of Good Manufacturing Practice (GMP). The department is subject to regular visits by senior management, external pharmaceutical companies and regulatory authorities. In order to achieve the high standards required, documented maintenance and calibration is an integral part of the daily routine. 2. Detailed Responsibilities/Accountabilities - Responsible for the Engineering electronic systems including IMS and CMMS. - Periodically review planned maintenance and calibration programmes, create trends and propose improvements to ensure optimum activities are carried out by the team. - Maintain the master drawings on site up to date including P&ID's, to create and issue CAD drawings when needed. - Perform the Installation Qualification (IQ) and Operational Qualification (OQ) of new plant and equipment and assist with the Performance Qualification (PQ). - Ensures all documentation is carried out to the highest standards and that all related timelines are maintained. - Provide and keep up to date any engineering SOPs as appropriate. - Ensure regulatory and statutory requirements are met for all equipment systems.