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Collins McNicholas

Overall Purpose:  

The EHS Specialist is responsible for developing and maintaining the Environment, Health and Safety programme for the site. This includes policy development, training of staff, ensuring legislative compliance, SOP development and more. The EHS specialist is the key representative on site for all EHS activities, both with regard to the ongoing construction, commissioning and qualification effort, as well as the day to day manufacturing which follows it. The EHS Specialist will report to the Engineering Team Leader.  

Essential Duties, Functions and Responsibilities:

  • Works with 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 Site 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.

Skills/Knowledge Required: 

  • Practical implementation of Health and Safety management systems
  • HAZOP execution
  • Very strong problem-solving skills, ideally using formal tools e.g. FMEA.
  • Technical knowledge of OELs and product containment
  • Experience with ATEX and Ex rated equipment a plus
  • IT skills and knowledge of Office packages (e.g. Microsoft Word, Excel)
  • Strong analytical skills, documentation skills and research skills.
  • Familiarity with pharmaceutical industry regulatory requirements.
  • Clear understanding of the needs of cGMP.
  • Specific knowledge of sterile pharmaceutical manufacturing processes and technologies a plus.
  • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently
    • Strong team player.
    • Good proactive approach & manner.

Education Required:

  • Bachelors Degree in Engineering or Science.  
  • Further qualification (Masters) in an EHS field ideal.

Experience Required:

  • At least 8 years relevant experience in a pharmaceutical manufacturing environment, with at least 5 years’ experience in a comparable EHS role.
  • Start-up experience (greenfield facility) a plus.

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