Job DescriptionAbout PSC BiotechWho are we?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. We serve 350 clients across more than 23 countries worldwide. Our services include cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing, and metrology services.‘Take your Career to a new Level’PSC Biotech disrupts the conventional consultancy model by offering a unique Employee Value Proposition, providing opportunities to work with talented professionals in the Pharma/Biotech industry. We offer permanent employment contracts with exposure to top pharmaceutical client sites in diverse cultural settings.Employee Value PropositionEmployees are the “heartbeat” of PSC Biotech. We offer empowering career development through in-house training, mentorship, and guidance to facilitate career progression. We aim to build high-performing teams that exceed client expectations in quality, stay within budget, and meet deadlines.OverviewWe are seeking a Senior Process Engineer for a 6-month contract within our Manufacturing, Science & Technology (MS&T) team. The role supports Upstream Manufacturing at a state-of-the-art facility producing biologics-based medicines, employing over 400 colleagues in a pivotal hub of biologics manufacturing.RequirementsRole Functions:Lead investigations, ensuring effective root cause analysis and CAPAs, data analysis, and interpretation to resolve complex cell culture deviations.Lead process improvement and troubleshooting with an end-to-end product focus.Support Industry 4.0 initiatives to enhance operations and data analytics in a digital environment.Provide technical support for new process introductions or changes in commercial manufacturing.Author and review batch documentation, technical reports, and support global regulatory submissions.Guide process engineering team members and IPT.Support process monitoring, trend analysis, and statistical process control to ensure process robustness.Lead or support initiatives to improve compliance and operational efficiency.Support development and PPQ batch execution.Identify risks and resolve issues promptly, ensuring project milestones are met through effective planning and execution.Experience, Knowledge & Skills:Proven collaboration and cross-functional leadership skills to drive continuous improvement and share best practices.Ability to initiate and lead change effectively.Strong communication and project management skills.Extensive experience with upstream processing, troubleshooting, Tech Transfer, regulatory filing, and commercial manufacture.Experience leading complex investigations and supporting regulatory inspections.Knowledge of current regulatory requirements and GMP standards.Qualifications & Education:Degree (or higher) in Science, Engineering, Technical field, or equivalent.Minimum of 6 years operational support (or 4+ years with Tech Support) in the Biopharma industry, with direct experience in USP biologics manufacturing, facility commissioning, qualification, validation, and startup.
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