Job Details: Equipment Process Engineer/Aseptic Sterile Fill Finish


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Equipment Process Engineer/Aseptic Sterile Fill Finish
Equipment Process Engineer (Aseptic Sterile Fill Finish)

Asset Recruitment is currently recruiting for Equipment Process
Engineers (Aseptic Sterile Fill Finish) the successful candidates will
be based onsite at a multinational Biopharmaceutical facility in
Carlow, Ireland. These roles will be for initial **Apply on the
website** month contract duration.

Duties:

* Defining and reviewing equipment specifications and associated test
documentation

* Troubleshooting equipment with particular emphasis on process cycles
- cleaning, sterilizing, containment

* Maintenance of process cleaning and sterilization cycles for new
product introductions

* Strong focus on disciplined Root cause analysis

* Coordinate the training of engineering/operations personnel on all
technology and process, ensuring cGMP compliance.

* Coordinating Facilities / Utilities Requirements

* Setup and maintain manufacturing area equipment in compliance with
the calibration and maintenance programs

* Participate in the internal EHS and Quality audits

* Lead engineering start up activities and new product introduction

Required Qualifications:

* Degree in Chemical or Process Engineering or equivalent

* Postgraduate Qualification in Engineering or Science discipline
advantageous

* Qualification in Project Management advantageous

Experience

* Min 5 years&#**Apply on the website**; work experience in a
Biologics or GMP environment as part of an Engineering, Technical
Services or operations function ideally with Fill Finish Operations,
Biologics Systems and Process knowledge.

* Execution of CQV of Process Equipment (e.g. Bioreactors / Process
Vessels, Chromatography, Ultrafiltration, Autoclaves, Parts Washers).

* Knowledge and experience with Facility Start-Up Projects (brown
field or green field).

* Equipment Vendor Package Ownership and System Design Coordination

* Technical Knowledge of process monitoring systems, automation
systems (DeltaV), Operational Intelligence & Data Systems (Pi System)
within a GMP manufacturing environment - beneficial and desirable but
not a necessity.

* Qualification of GMP Utilities, Systems and Processes - WFI, Clean
Steam, CIP, SIP.

* CQV of Lyophilisation equipment

* Troubleshooting and Providing Technical and Engineering Solutions
for GMP Manufacturing Operations and Equipment in a Biologics
Processing Environment.

* Full proficiency in automation and knowledge of GAMP5 and CFR**Apply
on the website** part **Apply on the website** compliance

* Cycle development and validation for sterile manufacturing

* Ability to understand engineering processes through a logical, data
driven hands on approach Equipment Process Engineer (Aseptic Sterile Fill Finish)

Asset Recruitment is currently recruiting for Equipment Process
Engineers (Aseptic Sterile Fill Finish) the successful candidates will
be based onsite at a multinational Biopharmaceutical facility in
Carlow, Ireland. These roles will be for initial **Apply on the
website** month contract duration.

Duties:

* Defining and reviewing equipment specifications and associated test
documentation

* Troubleshooting equipment with particular emphasis on process cycles
- cleaning, sterilizing, containment

* Maintenance of process cleaning and sterilization cycles for new
product introductions

* Strong focus on disciplined Root cause analysis

* Coordinate the training of engineering/operations personnel on all
technology and process, ensuring cGMP compliance.

* Coordinating Facilities / Utilities Requirements

* Setup and maintain manufacturing area equipment in compliance with
the calibration and maintenance programs

* Participate in the internal EHS and Quality audits

* Lead engineering start up activities and new product introduction

Required Qualifications:

* Degree in Chemical or Process Engineering or equivalent

* Postgraduate Qualification in Engineering or Science discipline
advantageous

* Qualification in Project Management advantageous

Experience

* Min 5 years&#**Apply on the website**; work experience in a
Biologics or GMP environment as part of an Engineering, Technical
Services or operations function ideally with Fill Finish Operations,
Biologics Systems and Process knowledge.

* Execution of CQV of Process Equipment (e.g. Bioreactors / Process
Vessels, Chromatography, Ultrafiltration, Autoclaves, Parts Washers).

* Knowledge and experience with Facility Start-Up Projects (brown
field or green field).

* Equipment Vendor Package Ownership and System Design Coordination

* Technical Knowledge of process monitoring systems, automation
systems (DeltaV), Operational Intelligence & Data Systems (Pi System)
within a GMP manufacturing environment - beneficial and desirable but
not a necessity.

* Qualification of GMP Utilities, Systems and Processes - WFI, Clean
Steam, CIP, SIP.

* CQV of Lyophilisation equipment

* Troubleshooting and Providing Technical and Engineering Solutions
for GMP Manufacturing Operations and Equipment in a Biologics
Processing Environment.

* Full proficiency in automation and knowledge of GAMP5 and CFR**Apply
on the website** part **Apply on the website** compliance

* Cycle development and validation for sterile manufacturing

* Ability to understand engineering processes through a logical, data
driven hands on approach

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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