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Engineering Compliance Specialist

Employer
NonStop Consulting
Location
Limerick
Salary
€70000 - €80000 per annum + Relocation Support
Closing date
Jun 23, 2019

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Sector
Science, Life Sciences, Cell and Molecular Biology
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate

Job Details

My client is the one of the fastest growing companies in the Biotech sector and is also recognised as a top employer on the European Market.

The job requires not only a sound technical knowledge but also the ability to think fast and on your feet as the manufacturing site is ever expanding and thus the conditions are always diff rent and with new challenges. Not only will this keep you on your toes on a day to day basis, but in the long run, it will offer you a wide range of skills and experiences that are sought after in the industry.

Summary: Responsible for ensuring cGMP compliance for the Ops Engineering & Automation Department.
Essential Duties and Responsibilities include, but are not limited to, the following:
* 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 department 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).


Experience And Required Skills :
Education and 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.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
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