Senior Utilities Compliance Engineer


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Location: Cork

Type: Contract

Rate: Negotiable


Reference: MT5188

Updated: 20/10/2017 16:50:17

Role Purpose:
The primary objective of the role will be to Identify, define & implement key processes and system improvements. Role will ensure that any compliance gaps identified will be remediated as appropriate.

Specific Responsibilities:

Knowledge of Utilities systems within the Bio pharma industry consisting of:
o WFI.
o Clean Steam
o Purified Water
o Nitrogen
•Process mapping, procedural review and development, work instructions review and deployment site wide. Support roll out of corporate Quality System Improvement Plan as relevant to Utilities.
•Support the Quality System to ensure on-going compliance and continuous improvement.
•Execute periodic reviews as per local procedures. When gaps or deviations are encountered ensure that CAPAs are raised. In some situations the compliance engineer will be responsible for closing the identified gaps.
•Review current SOP’s and ensure compliance to the corporate Quality Chapters.
•Participate in local change and CAPA boards
•Develop and implement systems for sustainable compliance and ensure the system can then be maintained.
•Conduct Audits to ensure conformance and effectiveness of the Quality System.
•Data and trend analysis and reporting.
•Observe and monitor trends relating to systems and processes and initiates improvements.
•Assist/coach the engineering team in completion of investigations, identification of root causes and establishment of robust corrective actions.
•In addition to supporting the site QMS the senior compliance engineer will be responsible for ensuring that all EHS and statutory requirements are being fulfilled by the site engineering department.

Knowledge, Experience and Skills:

•7+ years experience with a degree in chemical or mechanical engineering.
•Must have a good appreciation for designing systems within a GMP environment.
•Must have a thorough understanding and application of engineering principles, concepts, industry practices and standards.
•Must be able to provide solutions to moderately complex to semi-routine problems.
•Must have the ability to recognise deviations from accepted practice as required.
•Must be able to apply knowledge of current Good Manufacturing Practices (cGMPs).
•Must be able to exercise judgement within generally well-defined procedures and practices to determine appropriate action.
•Must be able to work under own initiative and remove road blocks.
•Self motivated and a drive for success.
•Normally receives no instruction on routine work and general instructions on new assignments.

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