HEAD OF ENGINEERING

Sintra RPK Biopharma is a global pharmaceutical company wishing to recruit Head of Engineering to assist our growing team. Head of Engineering (M / F) This is a position with wide ranging responsibilities that will require the delivery of challenging targets, prioritisation of a heavy workload and effective management of Engineering contractors. This candidate must have the ability to make informed decisions, ensure contractors follow instructions and work in accordance to company policies and procedures in a safe and responsible manner. Effective communication, problem solving, time and budgetary management and negotiation skills are essential Responsibilities: To conduct the detailed Engineering design of RPK’s manufacturing facilities and deliver the installation, commissioning and qualification plan on time, on budget To conduct systems, equipment (analytical and/or manufacturing) qualification and validation as per applicable regulations To deliver capital expenditure projects on site in compliance with company policies and procedures, regulatory and OHS standards To ensure that routine and preventive maintenance programs are coordinated in order to minimize User Area(s) downtime in line with cGMP To ensure that documentation associated with the routine and preventative maintenance of all equipment and site services is completed to a high standard in compliance with Quality standards To conduct risk assessments prior to routine and preventative maintenance on plant equipment and site services to ensure the maintenance activity is carried out is a safe manner (permit to work) To ensure any newly installed equipment breakdowns are fully investigated and CAPA plans are prepared and executed in a timely fashion To monitor manufacturing facility performance, plant downtime and in collaboration with User Area(s), conduct fault finding, root cause analyses as necessary to improve overall equipment effectiveness To work with the User Area(s) to develop maintenance and calibration schedules for systems, equipment (manufacturing and/analytical) and ancillary services Perform equipment criticality assessments for all newly installed manufacturing facilities To negotiate with equipment suppliers to provide equipment of the required quality at the lowest cost To prepare cost estimates for Engineering capital projects on site ensuring delivery of projects on time on budget To conduct formal Engineering handovers of commissioned systems, equipment (analytical and/or manufacturing) to User Area(s) following completion of Engineering capital projects To lead chemical reaction hazard, HAZID, HAZOP and process safety reviews as required prior to transfer of any chemical processes from the laboratory into pilot scale or full-scale manufacturing facilities To ensure that Engineering contractors are fully inducted and are competent to perform any construction or maintenance activities on site To work with regulatory authorities to ensure that site operations are compliant with regulatory requirements (e.g.: APA, Infarmed) To prepare, maintain and update standard operating procedures and process work instructions as required for the operation and maintenance of new systems, equipment (analytical and/or manufacturing) To perform investigatory and disciplinary meetings as required and directed by the Head of Operations Prepare monthly reports and submit to the Head of Operations in a timely manner Complete incident and accident investigations as required to minimize potential for recurrence Assist with regulatory bodies as necessary in the event of environmental or cGMP non conformance Develop a culture of reporting within the Engineering department Cooperate with the Head of Operations on Engineering budgetary issues To perform all reasonable duties as directed by the Head of Operations Profile: The ideal candidate will have a degree or equivalent in Engineering or Chemical Engineering. Solid knowledge of cGMP and Active Pharmaceutical Ingredient manufacturing. Solid experience in LEAN, OEE or other continuous improvement Good understanding of health and safety industry standards. Minimum of 5 years of relevant experience in a GMP compliant pharmaceutical manufacturing facility. Experience in Qualification and Validation of manufacturing and analytical systems and/or equipment. Experience in detailed engineering design. Chemical hazard and compatibility identification Hazard identification and operability studies Experience in Safety reviews Managing complex projects on time on budget and problem solving are essential. Relevant experience in operational control routines management (maintenance and calibration), management of preventive maintenance and calibration programmes. Flexibility and versatility; Excellent English both written and spoken. We offer: Full time position; Remuneration adjusted to function and experience; Work environment of excellence, focusing on quality; If you can picture yourself fulfilling this position, please send us your application. Tipo de oferta: Tempo Inteiro Idioma: inglês (Obrigatório) - há 2 horas