Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Dublin State/Province Dublin Country Ireland Job Description About PSC Biotech Ltd Who we are? 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 point 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 of 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 though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
The Project Engineer – New Syringe and AVI Lines Operations Readiness will report to the Operational Readiness Programme Lead within the Operations Function. They will be responsible for providing project management and engineering support for projects in the Operations Readiness Programme for the new syringe and AVI lines. The successful candidate will have five to eight years of experience within the pharmaceutical or biotech industry and will have demonstrated project management skills.
RequirementsThe ideal candidate will have: • Experience in a project engineering and management role in a pharmaceutical or biotech manufacturing facility engaging with site SMEs and managers along with global functions.
• The ability to influence and lead cross-functional teams to deliver their projects that ensure a smooth start-up of the new vial filling line.
• The ability to work independently and identify risks and mitigation pathways to ensure project delivery.
• A passion for continuous improvement applied to project management.
Scope of Role: • Arrange agreement among the project team, customers, and management on the goals of the project.
• Work with workstream leads to develop and maintain the Project schedule/plan that aligns with the overall goals of the Programme.
• Effectively communicate with everyone involved in the project.
• Have a controlled scope in place, which is understood by all stakeholders and maintained throughout completion of the project.
• Execute prudent risk and issue management.
• Maintain Actions/Risk and Decision logs.
• Generate and own the GMP change control.
• Motivate, support and direct project team members to deliver on project plan.
• Lead Team meetings and cross-functional collaboration.
• Work with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on time.
Compliance Related Tasks: • Always ensure compliance to cGMP
• Ensure safety & compliance standards are maintained to the highest standards.
• Ensure financial compliance in line with Business & Financial guidance.
• Support a culture of personal responsibility within reporting structure.
Skills & Knowledge: • High Energy and Commitment
• Ability to work independently.
• Comfortable leading across multiple stakeholders & multinational teams
• Strong ability to influence and affect change.
• Capable of resolving issues of conflict effectively
• A proven track record to transfer goals and objectives into measurable plans.
• Ability to identify gaps/risks and put appropriate remediation plans in place.
• Uses strong relationships to identify requirements and potential opportunities.
• Employs project management techniques and Problem Solving
• Provides leadership, guidance, and advice in own field of project management.
• Knowledge or experience with MES and EMBR projects
• Knowledge or experience with validation of Aseptic Filling Lines
Qualifications and Experience • Technical Degree and/or Masters' or equivalent
• Experience in a Life Science / Pharmaceutical / Biotechnology Environment
• Preferred Experience: Project Engineering & Management, Aseptic Filling Line Operations, MES/EMBR, Validation, Greenfield / Brownfield start up.
Systems / Equipment: • MS Office, MS Project, MS PowerPoint, and MS Visio,
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