* Industry Pharma/Biotech/Clinical Research
* Work Experience 4-5 years
* City Dublin
* State/Province Dublin
* Country Ireland
Job Description
About PSC Biotech
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 Employee Value Proposition as a unique selling point, offering the opportunity to work with a talented cohort of professionals in the Pharma/Biotech Industry. We offer a permanent contract of employment with exposure to top pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech. We provide empowering career development through in-house Learning & Development, mentorship, and guidance to facilitate career progression. We strive to build high-performing teams that exceed client expectations in quality, stay under budget, and meet timelines.
Overview
The MS&T Process Engineer delivers technical support to the Drug Substance Business: leading technical investigations within the Integrated Process Team, supporting significant projects across the site, and supporting design, construction and qualification of upstream & downstream equipment (when applicable), NPI/technology transfer and commercialization. The MS&T Process Engineer ensures that team objectives are met while ensuring compliance, safety and reliable supply to customers, and fostering an inclusive culture that energizes a Safety First, Quality Always, continuous improvement mindset.
Requirements
Primary Responsibilities
* Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in day-to-day activities and all applicable job functions, ensuring considerations of GMP impact and compliance in decisions.
* Design/Author/Review/Approve/Execute qualification documentation in line with the standard process.
* Lead experimental design of studies, execution, data analysis and interpretation. Author and review batch documentation, regulatory and technical documentation.
* Interpret trends observed in commercial process monitoring (e.g., proactive process analysis, continued process verification, statistical process control, multivariate analyses) for technical investigations and process changes to improve yield and robustness.
* Support the execution of development and PPQ batches, change control management and implementation.
* Lead multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus using Lean Six Sigma methodologies.
* Lead and facilitate investigations with effective Root Cause Analysis and CAPAs. Participate in audits and inspections.
* Lead and/or support site initiatives to improve compliance and overall operational efficiency. Serve as a key member during internal and external audits/inspections.
* Lead and support MS&T organizational initiatives as needed (e.g., safety, financial forecasting, work standardization).
* Maintain continuous focus on quality and safety compliance and on the customer.
Qualifications and Experience
* Demonstrated leadership and change management skills with a continuous improvement focus.
* Proven track record of delivering high performance through development and coaching of a team.
* Evidence of continuous professional development.
* Strong collaboration to promote knowledge sharing and implementation of best practices across the site.
* Motivation to be an inspiring member of a high performing team and a passion to build the future, with a desire to continuously learn and improve.
* Demonstrated interpersonal skills including flexibility, collaboration and inclusion; ability to work/upskill/coach a team environment.
Technical
* Subject Matter Expert in upstream/downstream processing and process control strategies. Working knowledge of analytics.
* Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
* Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
* Evidence of continuous professional development. Technical writing skills.
* Ability to articulate understanding of biologics processes to drive decision making, impact assessments, and design of studies in a multi-disciplinary team.
* Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes.
Minimum Education/Experience
* Relevant technical qualification in Applied Pharmaceutical/Biological/Chemical sciences or applied Technical/Engineering qualification.
* Experience leading technical-related projects.
* Experience with upstream cell culture and/or downstream purification of biological molecules.
* Experience preparing for and presenting in front of regulatory audits as SME.
* Experience with technology transfer, regulatory filing and commercial drug substance manufacturing of biologics is a plus.
* Technical operations experience in drug substance manufacture of biological molecules at commercial scale.
* Experience in drug substance process development, process characterization studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organizations for development and/or manufacturing.
* Experience in change management, deviations and CAPA management.
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