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. The Process Engineer -Packaging will provide technical engineering support and expertise to Packaging & Labelling Operations and ensure process engineering activities are implemented in a compliant manner.
Requirements
- Provide technical engineering support and expertise to Packaging & Labelling Operations including equipment performance monitoring, equipment recipe standardisation troubleshooting and process optimisation
- Represent Engineering on the Packaging & Labelling Operations Process Team and support to deliver uninterrupted supply of commercial product
- Fulfil system ownership responsibilities for all packaging equipment and associated automation recipes required for packaging operations
- Provide SME input as part of capital project team on design, qualification, cycle development and GMP release
- Implementation of equipment recipe updates required for artwork updates, SKU launch activities and technology transfers of new products
- Lead and support the investigation and resolution of equipment investigations, ensuring appropriate and effective CAPAs are put in place
- Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement and process optimisation using tools such as DMAIC, SMED and FMEA
- Provide coaching and support to the Packaging Operations and Process Engineering team to build their knowledge
- Partner with serialisation SMEs to ensure Packaging is ready to meet changing global requirements
- Participate in cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables
- Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities
- Ensure relevant documentation is prepared and updated in line with all Quality and regulatory guidelines and promotes full compliance to all GMP, environmental and safety requirements
- Instil the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence
- Ensure adherence to high standards of quality and support of a science and risk based quality culture
- Providing coaching and support to the Operations team to build their knowledge of packaging processes and associated recipes
- Ensures that all manufacturing methods and practices are consistent with industry and standards
- Maintains professional and technical knowledge by attending workshops, reviewing professional publications; establishing professional networks and participating in professional societies
Benefits
- Unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression
- Opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry
- Permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting
