Summary:
Our client, a biologics company based in Dublin is looking for a Commissioning and Qualification (C&Q) lead for a large scale Fill Finish Project in the Pharmaceutical Industry. Lead a team of C&Q engineers to ensure the C&Q activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

Responsibilities:

• Coordinates and supervises all C&Q activities.
• Approves C&Q planning documents detailing overall strategy for the project.
• Develops and approves the master list of C&Q test documents and activities.
• Reviews and approves all C&Q summary reports.
• Ensures the C&Q schedule is developed and maintained.
• Ensures all C&Q Engineers who perform C&Q activities have relevant training assigned.
• Pre-approval and post approval of C&Q test documents.
• Manages daily C&Q coordination meetings.
• Responsible for overall tracking and Reporting of C&Q status and risks/issues.
• Ensures startup of equipment/utilities is completed in a safe and coordinated manner.
• Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).

Qualifications & Experience:

• 6+ years experience in Engineering or Commissioning and Qualification Management.
• Technical qualification at third level or equivalent in Engineering.
• Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects.
• Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
• Knowledge of safety, GMP and environmental regulatory requirements.
• Demonstrated strong Communication and Leadership skills.
• Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
• Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry.

• Support the ongoing qualification and validation of all process equipment, facilities and utilities on site.
• Completion of periodic reviews on existing equipment.
• Actively support change controls.
• Support the management of ongoing equipment re-qualification requirements.
• Work cross functionally to develop and deliver annual equipment re-qualification requirements.
• Completes the development, review, and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.
• Ensures validation non-conformances or deviations are minimized during execution of CQV activities. For issues that do arise ensure they are closed out in a timely manner.
• Ensuring compliance with current industry regulations and guidelines relating to validation.
• Support department performance against defined KPIs.
• Participate in the control of Safety and Environmental programs. Adhere to safe working practices as set out in the Safety Statement and other company safety rules.
• Encourage actively the culture of teamwork and integration within the Engineering Services Department, and with all other Departments.
• Participate fully in cross-functional training initiatives.
• Participate in site EHS activities and ensure compliance with legislation and best practice.

• 3^rd level Engineering or Science Degree, or equivalent.
• At least three years of validation experience CQV within a pharmaceutical setting.
• Knowledge of validation practices and regulatory guidelines for a pharmaceutical facility.

• Create a strategy that will integrate security controls across a Linux infrastructure to the cloud
• Identify current risks and threats to IT Infrastructure
• Liaise with colleagues from various departments around various Security issues
• Assist in the development and implementation of the ISP
• Actively monitor new and emerging security and privacy related technologies, trends, issues, and solutions and assess their applicability to key business initiatives and strategies.
• Participate in Information Security Incident Response activities for the companies environment.
• Perform periodic and on-demand system audits and vulnerability assessments of systems, internal applications and Cloud services to identify security vulnerabilities.
• Monitor compliance with the organization's information security policies and procedures among employees, contractors and third parties.

• Degreed educated
• 6 years' experience in a technical/security orientated role
• Strong Linux experience including Deployment, lifecycle and Operations practices
• RedHat/CentOs system hardening experience
• Strong knowledge of NIS, Active Directory and IPA
• Previous experience with Docker, Kubernetes and securing container workloads
• Comfortable working in a fast paced environment
• Certified in security related area i.e. RHCE, CISSP, GCIA

• Excellent Salary
• Bonus
• Pension
• Health care

Superpedestrian is a world-leader in transportation robotics and human-scale mobility. 

Spun out of MIT in 2013, we specialise in artificial intelligence and electrified technologies. We launched our shared mobility division in 2020, using our proprietary shared e-scooter, LINK. Growth has been swift, and we now count Seattle, Rome and Madrid among the many cities we’re proud to serve. 

We’re excited at the prospect of introducing our pioneering safety technologies to Ireland, and we’re now looking for the right person to join our talented team to help us step into this beautiful country. This is a contract position for 6 months with opportunity to turn into a long term full time position.

What you’ll do

As our Policy Director (Ireland), you’ll introduce the brilliance of Superpedestrian’s home-grown micromobility safety tech and honest, courteous nature to your network of Irish transport, sustainability and planning decision-makers. 

You’ll develop innovative partnerships, foster close community ties, and identify opportunities for growth. You’ll delight in talking to the press about LINK, the “Volvo of e-scooters”, and its industry-leading safety and ergonomic features.

And, working closely with our European management, operations and communications departments, you’ll lay the groundwork that will enable us to continue our 100% clean record in city compliance and sustainable growth. 

This is a role that will expand as far as your ambition, and will put you at the forefront of technical innovation in this emerging sector.

Why you’d want to join us

We’re different. 

We are born of engineers, not venture capitalists. Our control centre and test labs are located in Cambridge, Massachusetts, alongside MIT and Harvard University. We have some of the sharpest minds in the industry, and we hold more than 30 patents for our amazing technologies. None of our competitors come close.  

LINK is the result of eight years developing our artificial intelligence-driven safety platform, and two years designing a robust chassis and efficient powertrain to match. We take our time to get our technology, our operations and our recruitment just right, because we think long-term. 

And we’re growing fast. You’ll have the opportunity to shape our company and the way we work, and make a real difference to communities in Ireland through our services. 

Who you are 

You’ll hold a Bachelor's degree or higher, with at least five years’ experience in government or government relations. Ideally, you’ll have a keen understanding of transportation policy, especially micromobility/mobility policy, be comfortable working with external consultants and organisations related to public policy issues, and have a rolodex full of great contacts.

What’s more important is that you have strong communication skills, both verbal and written, as you’ll be talking to press and government partners, and developing proposal materials. You’ll certainly be creative-minded, a big-picture thinker, and have a flair for strategy. 

Superpedestrian is a world-leader in transportation robotics and human-scale mobility. 

Spun out of MIT in 2013, we specialise in artificial intelligence and electrified technologies. We launched our shared mobility division in 2020, using our proprietary shared e-scooter, LINK. Growth has been swift, and we now count Seattle, Rome and Madrid among the many cities we’re proud to serve. 

We’re excited at the prospect of introducing our pioneering safety technologies to Ireland, and we’re now looking for the right person to join our talented team to help us step into this beautiful country. This is a contract position for 6 months with opportunity to turn into a long term full time position.

What you’ll do

As our Policy Director (Ireland), you’ll introduce the brilliance of Superpedestrian’s home-grown micromobility safety tech and honest, courteous nature to your network of Irish transport, sustainability and planning decision-makers. 

You’ll develop innovative partnerships, foster close community ties, and identify opportunities for growth. You’ll delight in talking to the press about LINK, the “Volvo of e-scootersâ€, and its industry-leading safety and ergonomic features.

And, working closely with our European management, operations and communications departments, you’ll lay the groundwork that will enable us to continue our 100% clean record in city compliance and sustainable growth. 

This is a role that will expand as far as your ambition, and will put you at the forefront of technical innovation in this emerging sector.

Why you’d want to join us

We’re different. 

We are born of engineers, not venture capitalists. Our control centre and test labs are located in Cambridge, Massachusetts, alongside MIT and Harvard University. We have some of the sharpest minds in the industry, and we hold more than 30 patents for our amazing technologies. None of our competitors come close.  

LINK is the result of eight years developing our artificial intelligence-driven safety platform, and two years designing a robust chassis and efficient powertrain to match. We take our time to get our technology, our operations and our recruitment just right, because we think long-term. 

And we’re growing fast. You’ll have the opportunity to shape our company and the way we work, and make a real difference to communities in Ireland through our services. 

Who you are 

You’ll hold a Bachelor's degree or higher, with at least five years’ experience in government or government relations. Ideally, you’ll have a keen understanding of transportation policy, especially micromobility/mobility policy, be comfortable working with external consultants and organisations related to public policy issues, and have a rolodex full of great contacts.

What’s more important is that you have strong communication skills, both verbal and written, as you’ll be talking to press and government partners, and developing proposal materials. You’ll certainly be creative-minded, a big-picture thinker, and have a flair for strategy. 

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The Band 1 – Desktop Technician will provide day to day local\remote desktop support, receive inbound calls, answer questions, troubleshoot and document steps performed to resolve challenges with hardware, software and application issues in a ticketing system. The candidate will also need to facilitate customer resolution for calls and engage their supervisors and managers to ensure operational consistency across all shifts within the IT Support Centre. Desktop Support Engineer provides Break Fix, fault diagnosis and resolution. Providing fault analysis to customer’s various core operating systems and platforms, as well be able to provide support and apply desktop fault resolution for the approved application suite. Ideal candidate should have 2-3 years’ experience in Windows Desktop support.

a)            Provide first/second level contact and problem resolution for customer issues.

b)            Work with Third Party Vendors to remediate complex AV issues as needed.

c)            Provide timely communication on issue status and resolution.

d)            Maintain ticket updates for all reported incidents.

e)            Install, upgrade, support and troubleshoot XP, Windows 7, Windows 8.1, Windows 10 and Microsoft Office 2010, Cisco Jabber, another authorized desktop application.

f)             Should have basic knowledge of Mac operating system, to support Apple pc users.

g)            Install, upgrade, support and troubleshoot for printers, computer hardware.

h)            Performs general preventative maintenance tasks on computers, laptops, printers.

i)             Performs remedial repairs on Desktops, laptops, printers and any other authorized peripheral equipment.

j)             Use diagnostic tools to troubleshoot problems associated with network connectivity, and workstation hardware/software.

k)            Broad experience of IT with basic understanding of Networks, Servers, Audio/Visual, Smart Devices and Telecoms.

l)             This position requires the ability to work in a project-based environment requiring flexibility and teamwork. Performs other duties as assigned.

Requirements

Education Details Preferred:

a)            Bachelor’s Degree or equivalent in Computer Science or related field.

b)            CompTIA A+, Microsoft Certified Professional (MCP) or better.

c)            Minimum of 18 months years of IT experience.

d)            Windows 7-10, Microsoft Active Directory, utilization of GPOs, MS Office 365, PC hardware installation and troubleshooting, Enterprise anti-virus solutions, Helpdesk ticketing systems.

e)            Mobile device management including IOS and Android devices, Enterprise encryption solutions, Windows PC/laptop management via Active Directory.

f)             Proven analytical, troubleshooting and problem-solving skills.

g)            Proven ability to multi-task, effectively determine priorities and meet SLA’s.

h)            Excellent communication relationship-building and internal customer service skills.

i)             Adaptable and flexible in a fast-changing industry and work environment.

j)             Willing to work off-hours and weekends when required for projects or emergency support.

LANGUAGE : LOCAL + English

What Experience Does the candidate need to have and No of years?