Industry: Pharma/Biotech/Clinical Research
Work Experience: 5+ years
Location: Dublin, Ireland
Job Description About PSC Biotech Who 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, serving 350 clients across 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 our unique selling points, offering the opportunity to work with a talented cohort of like-minded professionals in the Pharma/Biotech Industry.
We offer a permanent employment contract providing exposure to top pharmaceutical client sites in a diverse, multicultural work environment.
Employee Value Proposition Employees are the "heartbeat" of PSC Biotech.
We provide unparalleled career development through in-house training, mentorship, and continuous guidance to facilitate career progression.
We aim to create high-performing teams that exceed client expectations regarding quality, budget, and timelines.
Position Overview A new role has arisen within our growing Manufacturing, Science & Technology (MS&T) team for a 6-month contract as a Senior Process Engineer supporting Upstream Manufacturing at a state-of-the-art facility delivering lifesaving biologics medicines worldwide.
The site employs over 400 colleagues in a pivotal biologics hub.
Requirements Role 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 IPTs. Support data analysis and trend interpretation in commercial process monitoring, including proactive process analysis, continued process verification, statistical process control, and multivariate analyses. Support site initiatives to improve compliance and operational efficiency. Support the execution of development and PPQ batches. Identify and resolve issues and risks 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 knowledge sharing. Ability to initiate and lead change across the site. Strong communication and project management skills. Experience with upstream processing, troubleshooting, tech transfer, regulatory filing, and commercial manufacturing. 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 6 years of operational support (or 4+ years plus Tech Support) in the Biopharma industry, with direct experience in USP biologics manufacturing, facility commissioning, qualification, validation, and startup.
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