Industry: Pharma/Biotech/Clinical ResearchWork Experience: 4-5 yearsCity: DublinState/Province: DublinCountry: IrelandJob DescriptionAbout 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 EVP as one of the unique selling points, 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 to 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 through Learning & Development in-house training mentorship with constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our clients' expectations regarding the quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are met.
Job Description The Project/Equipment Engineer reports to the Senior Manager for Engineering Projects and is responsible for scoping and executing technical projects supporting Drug Product manufacturing within Formulation, Component Preparation, Vial/Syringe Filling, and Lyophilisation. This includes qualification of new equipment and implementation of associated reliability and maintenance programs.
RequirementsKey Responsibilities Project management and execution of assigned projects including project prioritization, resource management, status management, and external communication.Working with various stakeholders to scope projects and ensure requirements are satisfied. Project input will span from concept through design, construction, commissioning, and operation.Coordinating the introduction of new processes, equipment, and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up.Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.Ability to translate strategic/emerging technology solutions into pragmatic executable plans.Development and management of change controls.Participate as a member of multidisciplinary site and multisite teams.Development of detailed specifications, engineering documents, protocols, and standard operating procedures.Work in a collaborative manner within the Process Teams structure and contribute to Root Cause Investigations and Cross-Functional Investigations.Work collaboratively with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers, and Vendors to perform equipment upgrades and/or retrofits.Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies, and procedures.Support a safe working environment by complying with environmental health/safety practices, rules, and regulations.Travel may be required to support the execution of projects.Experience and Qualification: Bachelor's degree in engineering (Mechanical, Electrical, or Chemical) or relevant experience.Typically, 3+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly, Labelling, and Ancillary processes.Strong mechanical capability with hands-on experience in a technical role within a high-volume manufacturing environment is advantageous.Demonstrated experience in a GDP Compliant environment.Experience in MS Office, MS Project, Change Control & Document Management Systems.Proven ability to work cross-functionally, delivering technical solutions and implementing improvements.Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results.Technical report writing and communication/presentation skills.Ability to work to tight deadlines in a fast-moving environment.
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