Engineering Compliance Specialist

  • Location

    Munster, Republic of Ireland

  • Sector:

    Engineering

  • Job type:

    Permanent

  • Salary:

    Up to €0.00 per annum

  • Contact:

    Jack Conway-Kenny

  • Contact email:

    jack.conway-kenny@experis.ie

  • Job ref:

    BBBH103806_1559203557

  • Published:

    3 months ago

  • Expiry date:

    2019-06-29

Engineering Compliance Specialist

An Engineering Compliance Specialist is required to join a leading biotechnology manufacturing company based in Limerick. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

This role will be responsible for responsible for ensuring cGMP compliance for the Tech Ops Engineering & Automation Department. This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical/Biotech industry.

Key Responsibilities

  • Facilitates reviews and revisions of Department related SOP's, life cycle documents, plans and policies for each group within the Department.
  • Acts as a liaison between Engineering & Automation and onsite quality and regulatory groups to define and address compliance related items.
  • Identifies opportunities for continuous improvement of compliance and leads improvement initiatives.
  • Provides support, information, and assistance to individuals, groups and management with the initiation, review, submission, and follow-up of documents such as Change Controls, EOE's, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans.
  • Participates in investigations and root cause analysis for any issues of non-compliance.
  • Provides periodic reviews of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, preventative maintenance records/work orders, etc. to assess for compliance with established quality standards, policies and procedures.
  • Provides tracking and trending for maintenance of related compliance activities i.e. quality instances and PERs.
  • Participates in and obtains results of department quality and regulatory audits.
  • Specifies and coordinates training, OJT and SOP, for Automation, Engineering and contracted personnel.
  • Maintains knowledge of current good manufacturing practices (cGMPs).

Education/Experience

  • Requires BA/BS (engineering or scientific related field preferred) and 3+ years of related experience working in a cGMP environment or in the operation of an industrial facility. May substitute relevant experience in lieu of education.
  • Ability to work on own initiative, without direct supervision from management.
  • Team player with an ability to work well across various departments on site as well as business partners.
  • Excellent written, presentation, communication and investigation skills.
  • Deadline focused individual.

Interested? Contact Jack on 01-6455250, or Click Apply below!