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. Job Title:   Process Engineer   Role Description: ·         Reporting to the Associate Director Technical Engineering (CPEG), as Project Engineer you will lead and manage multiple Engineering projects from scope development, design, build/install and qualify through to handover to operations for key Engineering projects. This includes but is not limited to Process improvements, capital projects and Lean projects across multi-disciplined functions which may also require global and network support and collaboration. ·         The suitable person will typically have prior related project engineering experience; ideally in manufacturing, preferably GMP Setting with process engineering and/or validation experience in a sterile manufacturing environment. Requirements Role Functions: ·         Manage multiple projects from scope development, design, build/install and qualify through to handover to operations for key Engineering projects. ·         Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects. ·         Develop project scope, cost, and delivery time schedule for projects, working and collaborating closely with NPI leads to ensure integration into ongoing Validations and/or technical transfers. ·         Collaborate closely with cross functional teams to establish scope in improvement projects as we ramp up to a fully commercial site. ·         Be accountable for equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. And requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation ·         Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. ·         Act as a liaison with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business. ·         Comply with 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. Collaborate with multiple partners (e.g., Company network groups, third parties, vendors, quality, donor sites, Supply chain, IPT). ·         Presentations and reporting out on progress of projects to stakeholder as required. ·         Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on site activities. ·         May be required to perform other duties as assigned.   Experience, Knowledge & Skills: ·         Green Belt preferable ·         Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business. ·         Would have engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team through sustaining operations and technical transfer projects. ·         Experience in leading through change would be an advantage. ·         Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices ·         In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing ·         Experience of executing and/or managing through equipment and process design and validation in a sterile environment ·         Excellent report, standards, policy writing skills required. ·         Automation and MES knowledge ·         Proficiency in Microsoft Office and job-related computer applications required. ·         Lean Six Sigma Methodology experience desired. ·         Experience in audit preparation and execution desired. ·         Having a strong safety ethos ·         Have proven record of process improvement implementation. ·         Have a proven record of project management of change in a commercial site.   Qualifications & Education: ·         Bachelor’s degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline. #LI-AP1 Requirements Role Functions: · Manage multiple projects from scope development, design, build/install and qualify through to handover to operations for key Engineering projects. · Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects. · Develop project scope, cost, and delivery time schedule for projects, working and collaborating closely with NPI leads to ensure integration into ongoing Validations and/or technical transfers. · Collaborate closely with cross functional teams to establish scope in improvement projects as we ramp up to a fully commercial site. · Be accountable for equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. And requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation · Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. · Act as a liaison with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business. · Comply with 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. Collaborate with multiple partners (e.g., Company network groups, third parties, vendors, quality, donor sites, Supply chain, IPT). · Presentations and reporting out on progress of projects to stakeholder as required. · Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on site activities. · May be required to perform other duties as assigned. Experience, Knowledge & Skills: · Green Belt preferable · Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business. · Would have engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team through sustaining operations and technical transfer projects. · Experience in leading through change would be an advantage. · Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices · In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing · Experience of executing and/or managing through equipment and process design and validation in a sterile environment · Excellent report, standards, policy writing skills required. · Automation and MES knowledge · Proficiency in Microsoft Office and job-related computer applications required. · Lean Six Sigma Methodology experience desired. · Experience in audit preparation and execution desired. · Having a strong safety ethos · Have proven record of process improvement implementation. · Have a proven record of project management of change in a commercial site. Qualifications & Education: · Bachelor’s degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline.