Technical Operations Engineer

  • Cork
  • Contract
  • JO-1901-64211_1548927541


Technical Operations Engineer

Responsible for the following:

Active engagement with the Technical Operations team, delivering a successful outcome to all Technical Operations activities using Good Manufacturing Practices (GMP). These activities include, but are not limited to, Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Cleaning Validation, Process Validation, Change Control, Exception/Event Investigations/Closure.

As a Technical Operations Engineer, your typical day may include:

* Conduct Technical Operations activities in compliance with US and EU regulations, JSI procedures and EHS&S requirements.
* Develop Technical Operations documentation as required (e.g. strategies, plans, protocols, procedures, reports).
* Review and approve documents prepared by the Technical Operations.
* Execute Technical Operations protocols as required.
* Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
* Prepare reports for executed protocols for review and approval.
* Initiate and implement change control activities in accordance with site procedures.
* Track and resolve exceptions/events/deviations during Technical Operations activities.
* Prioritize Technical Operations activities in line with the project schedule.
* Co-ordinate Technical Operations activities with engineering, construction and commissioning activities.
* Co-ordinate Technical Operations activities with contractors and vendors as required.
* Co-ordinate Technical Operations document review and approval.
* Collate and organize Technical Operations files for turnover to QADC.
* Attend identified training, required to fulfill the role of a Technical Operations Specialist.
* Assist in the development of training material for Technical Operations activities.
* Deputise for the Technical Operations Lead or other team member where required.
* Domestic and international travel may be required.

Desirable Qualifications:

* To Bachelors Degree in a scientific/technical discipline required
* Experience in Validation (e.g. Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Cleaning Validation, Process Validation).
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply cGMP regulations and guidelines to all aspects of Technical Operations activities.
* Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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