Process Engineer

Job Description 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. Role Description:   Responsible for providing process, technical, and validation support to operations for commercial manufacturing and Process Simulation development and execution.   Accountable for all studies associated with the development of new components, products, processes systems and facilities in relation to process simulations.   Co-ordination, design, and execution of commercial & Process simulations studies as required. Requirements Role Functions: ·         Serve as technical support for manufacturing and new product introduction. ·         Design/Author/Review/Approve/Execute process simulations studies in support of new product introduction and ongoing manufacturing support. ·         Provide technical input into quality notification by authoring/reviewing/approving Process Simulation related investigations. ·         Design/Author/Review/Approve/Execute commercial & process simulation qualification/validation documentation and studies in line with the standard approval process. ·         Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis. ·         Support continuous improvement through Lean Six Sigma methodologies. ·         Leading and active participation in projects, system failure investigations and investigation reports, ·         Execution/development of change controls to support the Process Simulation process Contribution to Kaizen events as appropriate. ·         Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; ·         Implement subsequent corrective action through the change management system. Serve as technical engineering representative for internal technical group discussions and represent technical operations at global technical forums in relation to process simulations. ·         Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. ·         Drive compliance of client Global Policies, Procedures and Guidelines, regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance. ·         Work collaboratively to drive a safe and compliant culture. May be required to perform other duties as assigned.   Core Competences: Technical: ·         Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices ·         Report, standards, policy writing skills required ·         Equipment and process validation ·         Sterile filling processes and equipment ·         Proficiency in Microsoft Office and job related computer applications required ·         Lean Six Sigma Methodology experience desired Business ·         Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner ·         Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports ·         Customer service ·         Vendor liaison ·         Strong influencing skills ·         Self-motivated ·         Flexible approach ·         Effective time management and multi-tasking skills ·         Excellent attention to detail ·         Trouble shooting skills ·         Data Analysis ·         Goal/results orientated. ·         Demonstrable analytical and systematic problem solving skills ·         Training skills ·         Strong change management skills ·         Effective conflict resolution skills ·         Negotiation skills ·         Business acumen ·         Strategy development ·         Project management skills ·         Risk management skills ·         Progressive people management skills ·         Ability to effectively manage complex projects across multiple disciplines   Experience, Knowledge & Skills: ·         Typical Minimum Experience: ·         Experience in a Aseptic sterile manufacturing environment preferred ·         Demonstrated ability to coach and lead change. ·         Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment   Qualifications & Education: Typical Minimum Education: ·         Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical Discipline #LI-EB1 Requirements Role Functions: · Serve as technical support for manufacturing and new product introduction. · Design/Author/Review/Approve/Execute process simulations studies in support of new product introduction and ongoing manufacturing support. · Provide technical input into quality notification by authoring/reviewing/approving Process Simulation related investigations. · Design/Author/Review/Approve/Execute commercial & process simulation qualification/validation documentation and studies in line with the standard approval process. · Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis. · Support continuous improvement through Lean Six Sigma methodologies. · Leading and active participation in projects, system failure investigations and investigation reports, · Execution/development of change controls to support the Process Simulation process Contribution to Kaizen events as appropriate. · Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; · Implement subsequent corrective action through the change management system. Serve as technical engineering representative for internal technical group discussions and represent technical operations at global technical forums in relation to process simulations. · Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. · Drive compliance of client Global Policies, Procedures and Guidelines, regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance. · Work collaboratively to drive a safe and compliant culture. May be required to perform other duties as assigned. Core Competences: Technical: · Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices · Report, standards, policy writing skills required · Equipment and process validation · Sterile filling processes and equipment · Proficiency in Microsoft Office and job related computer applications required · Lean Six Sigma Methodology experience desired Business · Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner · Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports · Customer service · Vendor liaison · Strong influencing skills · Self-motivated · Flexible approach · Effective time management and multi-tasking skills · Excellent attention to detail · Trouble shooting skills · Data Analysis · Goal/results orientated. · Demonstrable analytical and systematic problem solving skills · Training skills · Strong change management skills · Effective conflict resolution skills · Negotiation skills · Business acumen · Strategy development · Project management skills · Risk management skills · Progressive people management skills · Ability to effectively manage complex projects across multiple disciplines Experience, Knowledge & Skills: · Typical Minimum Experience: · Experience in a Aseptic sterile manufacturing environment preferred · Demonstrated ability to coach and lead change. · Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment Qualifications & Education: Typical Minimum Education: · Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical Discipline #LI-EB1