Title

Executive Assistant

Executive Assistant

Executive Assistant in a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs. The company has a portfolio of medicines through its orphan, primary care and rheumatology business units.
Position Summary
The Executive Assistant provides a wide range of high level administrative support the VP, Manufacturing, as well as the Site Leadership Team (SLT). This role requires strong initiative, and the ability to effectively prioritise and handle a diversified workload in a confidential and sensitive manner.
Responsibilities
  • Act as point person for the VP, Manufacturing within a busy manufacturing facility in Waterford
  • Provides comprehensive support services to the Site VP, as well as the SLT that ensures a professional, responsive and effective experience with the organisation as a whole
  • Assist with preparation for team meetings including invite attendees, agenda management, slide preparation
  • Provides support to the efficient execution of the site’s readiness programme and its governance – maintenance of risk profile, action logs, meeting minutes, monthly newsletter, steering meeting management etc
  • Support preparation of agendas, reports and presentations with high standards of accuracy
  • Maintain actions logs, following up with other staff to verify status of actions
  • Coordinate with the facilities team on site infrastructure and on events both on and offsite
  • Act as a Waterford counterpart for administration teams based in Dublin, the US and Germany
  • Provides sophisticated calendar management. Prioritises inquiries and requests while troubleshooting conflicts with little guidance; makes judgements and recommendations to ensure smooth day-to-day engagements
  • Responsible for managing the VP, Manufacturing travel arrangements as well as tracking travel expenses by managing credit cards and receipts. Process and submits receipts and expenses accurately and on schedule
  • Communicates routinely with other Horizon sites to ensure appropriate coordination of executives’ schedules and activities
  • Assist with specific departmental on-boarding for new team members
  • Support work to maintain and promote the Horizon culture in the Waterford office
Qualifications and Skills Required:
• 7+ years of proven success supporting executives in a fast-moving environment
• Advanced proficiency in Microsoft Office suite
• Displays excellent communication and interpersonal skills
• High professionalism, organisation and detail-orientation
• The ability to handle sensitive and confidential information discreetly
• Enjoys working in a collaborative environment

Analytical Chemist

Analytical Chemist

Analytical Chemist required by our multinational biopharmaceutical client based in Waterford City. Our client is focused on improving patients' lives through commercialising quality, innovative medicines prescribed by primary care physicians, specialists and those who treat patients with rare diseases.The company markets a portfolio of medicines through its orphan, primary care and rheumatology business units.
The position
The Analytical Chemist reports to the Quality Control Manager and is responsible for analytical method transfers, method validations/verifications, with minimum supervision. The candidate will be responsible for troubleshooting any OOS/OOT results that are generated in the Analytical Laboratory. The candidate will be responsible for generating and reviewing analytical method validation/transfer protocols, managing laboratory supplies for method transfer/validation. The candidate will be an integral part of the day to day operation of the Analytical laboratory and supporting site activities. The candidate will help prepare and maintain an inspection ready status within the laboratory to support regulatory audits. Experience with analysis of biologics including bioassays is highly desirable.
Responsibilities
  • To perform routine analytical activities as required to support day to day laboratory operations.
  • To perform analytical testing.
  • To prepare and execute method transfer protocols and generate reports.
  • To perform method validation/compendial method verification.
  • To be actively involved in internal investigations e.g. Laboratory Out of Specifications, Incidents & Deviations etc.
  • To ensure that all work is carried out in compliance with the required company standards and conforms to cGxP, relevant SOPs, safety and environmental guidelines.
  • To identify continuous improvement opportunities.
  • To Implement Health & Safety requirements as per site documentation including SOPs, Safety Statement
  • Report any defects or potential hazards.
Qualifications and Skills Required:
  • Minimum of Bachelor's degree in pharmaceutical sciences/chemistry or
  • chemical/bioengineering.
  • 5-years' experience in the pharmaceutical industry
  • Experience in analytical method development, method validations, development, optimization, validation, continuous improvement, trouble shooting, tech transfer, operations, risk analyses/FMEA for drug substance (small molecules), drug product
  • Data analysis and presentation skills
  • Problem solving skills
  • Sterile/Biologics experience required.
  • Understanding of US, EU, and ICH Good Manufacturing Practices regulation concepts
  • Strong and effective interpersonal skills and demonstrated leadership in a fast-paced company.
  • Team player
  • Ability to communicate clearly and concisely verbally and in writing
  • Working in the Laboratory as and when required.

Engineering Manager

Engineering Manager

Engineering Manager required for a new multinational biopharmaceutical company based in Waterford City. The company is focussed on improving patients’ lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs. The company has a portfolio of medicines through its orphan and inflammation groups. The Engineering Manager will report to the Head of Operations and will be responsible for the following areas:
  • Site Maintenance Systems & Strategy
  • Engineering & Maintenance Team Performance
  • Site Utilities operation & maintenance (Black & Clean)
  • Site facilities & building services
  • Site Calibration
  • Site Automation & IT
  • Site Manufacturing Systems
  • Site Health, Safety & Environmental Systems
  • Management of FM support service & performance
  • Equipment performance metrics (OEE, d/time, etc.)
  • Energy management
  • Engineering budgets
Responsibilities
  • Manages the Engineering, Maintenance, Automation/IT and Facilities resources including technicians, engineers and contract resources/partners required to support site objectives.
  • Engineering team recruitment, performance management, training and development plans.
  • Leads the design, introduction and management of site maintenance systems such as CMMS, spares, safety permitting for Engineering and Maintenance personnel.
  • Ensure FUE management system is in place so that we maintain Facilities and Utilities to best in class level, with timely upkeep and reinvestment and delivering energy reduction and sustainability programs & projects.
  • Develop a culture of continuous improvement.
  • Owns site energy, waste performance, energy and waste budgets. Monitors site performance from a budget and environmental perspective. Leads continuous improvement in this area and leads site representation at EHS and Environmental audits.
  • Owns maintenance Service Level Agreements (SLA) and spares budgets to ensure the site is maximising benefit from site maintenance spend.
  • Coordinates site shutdowns from planning, execution, return to service, safety and GMP perspective.
  • Ensures all personnel in their team are diligent in the completion of all documentation to the highest GMP standards.
  • Manages the Horizon Automation team who are responsible for the support of automated systems on site.
  • Ensuring site asset management is compliant with HSA equipment and leads establishment and maintenance of the site’s relationship with our insurers.
  • Represent the site for maintenance/utility in front of HPRA/ FDA / HSA inspectors during audits.
  • Ensure certified EHS Management Systems are in place and maintained
  • Ensure an interdependent safety culture model is put in place
  • Ensure Environmental compliance with our Regulatory Licences
Qualifications, Skills & Experience Required
  • Degree in Building Services/Mechanical/Electrical Engineering or equivalent technical certification/trade in a business service, mechanical, electrical or related field.
  • Postgraduate degree desirable.
  • 15+ years of directly related engineering/maintenance experience in a regulated manufacturing environment
  • 5+ years management experience – building and leading an Engineering team in a pharmaceutical manufacturing environment
  • Understands maintenance system design to ensure excellent asset performance.
  • Familiar with pharmaceutical utility equipment such as WFI generation & distribution, clean steam generation & distribution, cleanroom HVAC, steam boilers, air compressors, etc.
  • Strong technical, troubleshooting and problem-solving skills.
  • Proficient in use of Microsoft Office and other computer applications i.e. CMMS.
  • Knowledgeable of the regulatory and GMP requirements for maintenance activities. Direct experience of HPRA and FDA inspections.
  • Familiar with EHS and Environmental standards.
  • The role will typically require infrequent, off site national and international travel, for business or equipment/project review meetings, including overnight stays, up to 10% of the time.

Senior EHS Specialist

Senior EHS Specialist

Senior Environmental Health & Safety Specialist required by our client, a Multinational biopharmaceutical company based in Waterford City focused on improving patients’ lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs. The company has a portfolio of medicines through its orphan and inflammation groups.
Reporting to the Engineering Lead, The overall job purpose
1) The Senior EH&S Specialist is responsible for developing and maintaining the Environment, Health and Safety programme for the Horizon Waterford site. This includes policy development, training of staff, ensuring legislative compliance, SOP development and more.
2) The Senior EH&S specialist is the key representative on site for all EHS activities, both regarding the ongoing construction, commissioning and qualification effort, as well as the day to day manufacturing which follows it.
Responsibilities include:-
  • Works with MSAT (Tech Services), Manufacturing and Quality colleagues as part of an Operations team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
  • Supports capital projects throughout equipment lifecycle.
  • Develop EHS policies and procedures to ensure compliance with the latest legislation and industry best practice.
  • To develop all site safety systems, programmes and standards and to deliver high quality Health and Safety training and technical support.
  • Participation in HAZOP execution
  • To provide guidance to management and staff by interpreting health and safety legislation, policies and industry guidance.
  • Development of systems, programmes and standards to meet the requirements of existing and future legislation and corporate policy standards.
  • To ensure company compliance with all Health and Safety standards
  • Liaise with onsite security functions, waste handling control and management for hazardous and non-hazardous waste streams.
  • Provision of Health & Safety technical advice to management and workforce.
  • Interpretation and application of legislation, industry good practice guidance and corporate policies.
  • Oversee development and continuous improvement of risk assessment and other programmes to meet regulatory and corporate requirements.
  • Drive compliance and continuous improvement in H&S performance through auditing and training.
  • Ensure adequate provision of Health and Safety training for workforce.
  • Investigate and provide legislative guidance during incident response.
  • Review process and equipment changes to identify potential, H&S impacts.
  • Collaboration with site manufacturing and technical support personnel to manage Health & Safety aspects of processes.
  • Participate in process flow team / contractor Health and Safety meetings and active monitoring.
  • Key responsibility for delivery of internal audit programmes and periodically evaluating compliance with H&S legal requirements.
  • Liaising with and reporting to regulatory agencies such as the EPA and relevant agencies such as Irish Water.
The ideal candidate will have:-
  • Bachelor’s Degree in Engineering or Science.
  • Further qualification (Masters) in an EHS field ideal.
  • At least 10+ years relevant experience in a pharmaceutical manufacturing environment, with at least 5 years’ experience in a comparable EHS role.

On Site IT Support Specialist

On Site IT Support Specialist

IT Support Specialist required by our client a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs. The company has a portfolio of medicines through its orphan and inflammation groups.
Reporting to the Senior Manager, IT Support at Head Office, we are seeking a highly talented and self-motivated individual to join the Information Technology team as an IT Support Specialist.
You should be detail-oriented and skilled across all areas of enterprise desktop and end-user support. Capable of working independently or in a team setting, you possess the desire and attitude to deliver high quality IT solutions. This position will support end user systems, including PCs, mobile devices, printers/copiers, and telephones.
Responsibilities
  • Provide Tier-1 help desk support for both office employees and mobile/remote users including:
    • Technical support of end-users in-person and via telephone.
    • Documentation, tracking, and resolution of all support incidents in a timely and efficient manner.
    • Fulfillment of move/add/change requests for end-user workstations.
    • Third-party vendor support.
    • Coordination and communication with global IT resources (both company employees and contract resources).
    • Conduct IT on-boarding and off-boarding activities for new or separated employees.
    • Provide executive meeting support.
    • Proactively seek to improve desktop infrastructure, end-user support services, and enterprise desktop management
  • Contribute to IT project initiatives by assisting with the design and implementation of server-side systems that facilitate desktop deployment and management. These initiatives include:
    • Desktop security including antivirus, patching, and update management
    • Asset tracking and inventory management
    • Office telephony
    • Mobile device administration including tablets and smartphones
    • Device data protection and backups
    • Remote support tools
    • SCCM Administration
  • Assume ownership for the following IT operations-related activities:
    • Support of Company Operations and Facilities initiatives such as maintenance of leased equipment
    • IT Server Room maintenance
  • Work independently and as a team to accurately resolve high-level technical issues, including conducting necessary research and testing to determine root-cause of support incidents
  • Manage time efficiently to multitask project contributions alongside daily operational tasks.
  • Interact with all levels of Company staff, including the Executive Team.
Qualifications and Skills Required
  • 2+ years of direct hands-on experience deploying, maintaining, and troubleshooting Windows desktop operating systems, desktop applications, and network connectivity (MCP not required but strongly desired).
  • Hands-on experience deploying and managing mobile devices such as tablets and smartphones.
  • Competency working with the following technologies, or equivalent related skillsets, based on experience in years specified above:
    • Active Directory and Group Policy
    • Office 365 (SharePoint, Exchange)
    • Application delivery (Microsoft)
    • Scripting (PowerShell and VBScript) advantageous but not essential
    • Desktop/endpoint security (Sophos)
    • Data backup and protection software
    • Mobile device management suites
    • Desktop performance and connectivity troubleshooting and analysis
    • Hardware and software diagnosis and break-fix
    • Peripherals and network printer configuration
    • Microsoft Office configuration and troubleshooting (Office 2016)
    • VoIP Telephony advantageous
    • Help Desk ticketing software suites and remote access tools
  • Prior experience working in a pharmaceutical manufacturing plant is desireable

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