Job Details: Process Engineers


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Process Engineers
Position: Process Engineers X 3

Working on the construction project for the expansion of a
pharmaceutical plant

As part of a significant expansion of the Company site, an exciting
opportunity has come to be part of the technical transfer of key
products for the new facility presently in construction.

As part of the Technical Transfer team you will be responsible for the
transfer of a syringe and/or vial product from the existing Carlow
line to the newly expanded facility, and a formulation process for the
syringe filling process from a US site to Carlow. .

The role will include helping to build and execution of the technical
transfer plan for the product. Early engagement with the construction
team ensuring that process requirements will be embedded during the
construction phase of the project (equipment and facility). Ultimately
working towards the goal of completing the Product and Process
Qualification batches in **Apply on the website**.

Reporting to the Technical Transfer Lead and the role will include -

* Execute process engineering activities to support the technical
transfer of products to site. This includes but is not limited to:
cycle development, Equipment PQ, PPQ&#**Apply on the website**;s,
Cleaning, PCM, CTU mapping, filter validation, etc.

* Engage in the early stages of the project, giving input into design
by working with equipment vendors and global engineering teams to
ensure that the process and product requirements are met.

* Providing technical and product guidance to the process, design and
project delivery teams.

* You will be required to Author and review procedures and technical
reports required as part of the technical transfer.

* You will be Technical review and approval of Validation protocols
executed by vendors, cross functional groups and/ or validation
counterparts.

* You will be leading or supporting component criticality assessments
for the process.

* Executing activities as part of the Change Management process for
the product introduction.

* Effective application of LeanSixSigma and Change Management tools.

* Represent the site in internal collaborations through Manufacturing
Division Validation Communities of Practice to include sharing of best
practices.

* Keep up to date with scientific and technical developments, best
practices and attend seminars as required.

* Maintain continuous focus on quality and safety compliance and
unflinching focus on the customer.

THE QUALIFICATIONS / EXPERIENCE

* Minimum of 3 years directly related experience in academia,
pharmaceutical or biotechnology industry - along with a working
knowledge of current regulatory requirements and current Good
Manufacturing Practices.

* A self-starter and results-focussed, the successful candidate will
have strong contemporary knowledge, and the ability to work
independently and on multidisciplinary teams.

* Process or technical transfer experience.

* Working knowledge of ASTM E**Apply on the website** / Eudralex / FDA
/ ISPE guidelines

* Experience with liaising with other departments - engineering,
technical, operations, QA and Regulatory Affairs.

* Experience with sterile processing and sterilisation technologies

* Prior experience in drug product processing equipment, PQ, Process
Performance Qualification and Validation, site readiness, batch record
reviews, authoring documents subject to regulatory inspection.

Desirable but not essential

* Experience with cleaning and process validation, technology
transfer, regulatory filing, and commercial drug product manufacturing
of biologics is a plus.

* SME on Equipment within a sterile fill finish environment; e.g. CIP
& Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation
/ Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities
Transfer Panels & Formulation Vessels

* Vial / Syringe processing technologies; drug product filling, glass
handling, tray handling, stoppering, capping and CCI.

* New facility brown/ green field facility experience

* Small equipment qualification and validation; FITs, Scales, Tube
Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels &
Single Use Technologies Position: Process Engineers X 3

Working on the construction project for the expansion of a
pharmaceutical plant

As part of a significant expansion of the Company site, an exciting
opportunity has come to be part of the technical transfer of key
products for the new facility presently in construction.

As part of the Technical Transfer team you will be responsible for the
transfer of a syringe and/or vial product from the existing Carlow
line to the newly expanded facility, and a formulation process for the
syringe filling process from a US site to Carlow. .

The role will include helping to build and execution of the technical
transfer plan for the product. Early engagement with the construction
team ensuring that process requirements will be embedded during the
construction phase of the project (equipment and facility). Ultimately
working towards the goal of completing the Product and Process
Qualification batches in **Apply on the website**.

Reporting to the Technical Transfer Lead and the role will include -

* Execute process engineering activities to support the technical
transfer of products to site. This includes but is not limited to:
cycle development, Equipment PQ, PPQ&#**Apply on the website**;s,
Cleaning, PCM, CTU mapping, filter validation, etc.

* Engage in the early stages of the project, giving input into design
by working with equipment vendors and global engineering teams to
ensure that the process and product requirements are met.

* Providing technical and product guidance to the process, design and
project delivery teams.

* You will be required to Author and review procedures and technical
reports required as part of the technical transfer.

* You will be Technical review and approval of Validation protocols
executed by vendors, cross functional groups and/ or validation
counterparts.

* You will be leading or supporting component criticality assessments
for the process.

* Executing activities as part of the Change Management process for
the product introduction.

* Effective application of LeanSixSigma and Change Management tools.

* Represent the site in internal collaborations through Manufacturing
Division Validation Communities of Practice to include sharing of best
practices.

* Keep up to date with scientific and technical developments, best
practices and attend seminars as required.

* Maintain continuous focus on quality and safety compliance and
unflinching focus on the customer.

THE QUALIFICATIONS / EXPERIENCE

* Minimum of 3 years directly related experience in academia,
pharmaceutical or biotechnology industry - along with a working
knowledge of current regulatory requirements and current Good
Manufacturing Practices.

* A self-starter and results-focussed, the successful candidate will
have strong contemporary knowledge, and the ability to work
independently and on multidisciplinary teams.

* Process or technical transfer experience.

* Working knowledge of ASTM E**Apply on the website** / Eudralex / FDA
/ ISPE guidelines

* Experience with liaising with other departments - engineering,
technical, operations, QA and Regulatory Affairs.

* Experience with sterile processing and sterilisation technologies

* Prior experience in drug product processing equipment, PQ, Process
Performance Qualification and Validation, site readiness, batch record
reviews, authoring documents subject to regulatory inspection.

Desirable but not essential

* Experience with cleaning and process validation, technology
transfer, regulatory filing, and commercial drug product manufacturing
of biologics is a plus.

* SME on Equipment within a sterile fill finish environment; e.g. CIP
& Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation
/ Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities
Transfer Panels & Formulation Vessels

* Vial / Syringe processing technologies; drug product filling, glass
handling, tray handling, stoppering, capping and CCI.

* New facility brown/ green field facility experience

* Small equipment qualification and validation; FITs, Scales, Tube
Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels &
Single Use Technologies

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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