About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Description: Position Description(s) Title: Injection Moulding Project Engineer Job Purpose: Primary responsibility to provide polymer processing and engineering expertise for a range of products and materials. Also responsible for identifying and implementing innovative engineering technologies, which will deliver highly efficient and cost-effective processes and equipment. Responsibilities: Main areas of responsibility: − Performs planning, development, facilitation of design and installation of Injection Molding equipment and processes. − Ensures that molding equipment meets company specifications, schedules and budgets. − Develops and executes equipment validation testing (I/O, Safety Matrix, SAT, IQ, OQ, PQ etc.) for the qualification of new Injection Moulding equipment. − Provide troubleshooting expertise to resolve Injection Molding equipment, systems and process problems using strong statistical methodology. − Develop technical problem-solving skills among Process Technicians. − Provide key inputs and leadership into transformational process developments. − Project Management - provide timely and accurate reporting on project activities. − Lead or actively participate in cross-functional teams to ensure New Product Introduction/Research and Development projects are completed in a timely and efficient manner. − Actively interfacing with cross-functional team members, always practicing good teamwork in support of day to day operating requirements. − Demonstrate strong leadership and a clear identifiable work ethos within the team. − Develop and maintain a Credo & Behavioural Standards based culture within the group. − Ensure effective closure on Quality System documents (Audit Actions, NCR’s, CAPA’s, Maps, etc.). − Ensure all process developments, NPI etc. are managed in accordance with the Quality management system. − Work with team leader to develop and implement strategic engineering Goals & Objectives. − Support the implementation of all engineering and plant strategic initiatives. − All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform. Requirements Education and Experience Required for Role Essential: − Degree in Mechanical or Polymer Science or similar disciplines. − Minimum 4 yeas relevant industrial experience. Desirable: − Proven track record in Injection Moulding Engineering. − Experience in a validated Medical Device environment. − Knowledge of equipment installation and validation – I/O, Safety Matrix, SAT, IQ, OQ, PQ, etc.). − Ability to manage multiple assignments or projects with sound analytical, troubleshooting, and problem-solving skills. − Flexible work ethic. − Strong influencing skills. − Excellent communication skills (written and oral). − Problem solving skills. − Decision making – required to make decisions on technical issues. − Degree of responsibility – must be capable of taking direction and taking responsibility and ownership for systems. #LI-AM1