Job Details: Technical Engineering Specialist/Product Introduction / Pharma


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Technical Engineering Specialist/Product Introduction / Pharma
Position: Technical Engineering Specialist (New Product Introduction
/ Pharma)

We are one of the largest, best known Pharmaceutical companies in the
industry and our products are known globally.

We are looking to recruit an Experienced Technical Validation
Specialist to join us on an initial **Apply on the website** month
contract. You will be responsible for providing process, technical,
and validation support operations including ongoing support of
manufacturing processes and support for new product introduction.

The post holder will also be accountable for analytical/engineering
studies associated with the development of new components, products,
processes systems and facilities. Co-ordination, design and execution
of equipment qualification.

Further responsibilities include:

* Serve as technical and/or validation support as required for
manufacturing and new product introduction.

* Design/Author/Review/Approve/Execute process development studies in
support of new product introduction and ongoing manufacturing support.

* Provide technical input into quality notification by
authoring/reviewing/approving investigations.

* Execution of equipment commissioning and qualification programs

* Execution of equipment/qualification validation programs; including
re-qualification and re-validation

* Design/Author/Review/Approve/Execute qualification/validation
documentation and studies in line with the standard approval process

* Perform data analysis and make informed decisions/recommendations
around conclusions reached from data analysis

* Support continuous improvement through Lean Six Sigma methodologies.

* Leading and active participation in projects, system failure
investigations and investigation reports,

* Execution/development of change controls

* Perform root cause analysis of system failures, substandard
performance, using standard tools and methods, to resolve machine and
system issues e.g. FMEA, Fishbone diagrams, 5 why&#**Apply on the
website**;s etc.;

* Implement subsequent corrective action through the change management
system.

* Serve as technical engineering representative for internal technical
group discussions and at global technical forums.

* Participate and/or lead cross functional or single function teams
including liaising with vendors or above site groups.

Skills and Qualifications Required:

* Bachelor&#**Apply on the website**;s Degree or higher preferred;
ideally in a Science, Engineering or other Technical discipline

* Previous experience in a similar role within a GMP Setting

* Prior knowledge of regulatory/code requirements to Irish, European
and International Codes, Standards and Practices

* Report, standards, policy writing skills required

* Equipment and process validation

* Sterile filling processes and equipment

* Proficiency in Microsoft Office and job-related computer
applications required

* Lean Six Sigma Methodology experience desired

Please press apply now to submit your application. Alternatively, if
you would like further information on this position or other positions
win a similar sector, please feel free to contact our team on (phone
number removed) for a confidential conversation.

We are an equal opportunities Business. We welcome applications from
all suitably qualified candidates regardless of their race, sex,
disability, religion/belief, sexual orientation or age.

Each company within the Planet Equity Group is a "data controller".
This means that we are responsible for deciding how we hold and use
personal information about you in line with GDPR guidelines. Full
details regarding how we hold your data is available within our
Privacy Notice accessible Position: Technical Engineering Specialist (New Product Introduction
/ Pharma)

We are one of the largest, best known Pharmaceutical companies in the
industry and our products are known globally.

We are looking to recruit an Experienced Technical Validation
Specialist to join us on an initial **Apply on the website** month
contract. You will be responsible for providing process, technical,
and validation support operations including ongoing support of
manufacturing processes and support for new product introduction.

The post holder will also be accountable for analytical/engineering
studies associated with the development of new components, products,
processes systems and facilities. Co-ordination, design and execution
of equipment qualification.

Further responsibilities include:

* Serve as technical and/or validation support as required for
manufacturing and new product introduction.

* Design/Author/Review/Approve/Execute process development studies in
support of new product introduction and ongoing manufacturing support.

* Provide technical input into quality notification by
authoring/reviewing/approving investigations.

* Execution of equipment commissioning and qualification programs

* Execution of equipment/qualification validation programs; including
re-qualification and re-validation

* Design/Author/Review/Approve/Execute qualification/validation
documentation and studies in line with the standard approval process

* Perform data analysis and make informed decisions/recommendations
around conclusions reached from data analysis

* Support continuous improvement through Lean Six Sigma methodologies.

* Leading and active participation in projects, system failure
investigations and investigation reports,

* Execution/development of change controls

* Perform root cause analysis of system failures, substandard
performance, using standard tools and methods, to resolve machine and
system issues e.g. FMEA, Fishbone diagrams, 5 why&#**Apply on the
website**;s etc.;

* Implement subsequent corrective action through the change management
system.

* Serve as technical engineering representative for internal technical
group discussions and at global technical forums.

* Participate and/or lead cross functional or single function teams
including liaising with vendors or above site groups.

Skills and Qualifications Required:

* Bachelor&#**Apply on the website**;s Degree or higher preferred;
ideally in a Science, Engineering or other Technical discipline

* Previous experience in a similar role within a GMP Setting

* Prior knowledge of regulatory/code requirements to Irish, European
and International Codes, Standards and Practices

* Report, standards, policy writing skills required

* Equipment and process validation

* Sterile filling processes and equipment

* Proficiency in Microsoft Office and job-related computer
applications required

* Lean Six Sigma Methodology experience desired

Please press apply now to submit your application. Alternatively, if
you would like further information on this position or other positions
win a similar sector, please feel free to contact our team on (phone
number removed) for a confidential conversation.

We are an equal opportunities Business. We welcome applications from
all suitably qualified candidates regardless of their race, sex,
disability, religion/belief, sexual orientation or age.

Each company within the Planet Equity Group is a "data controller".
This means that we are responsible for deciding how we hold and use
personal information about you in line with GDPR guidelines. Full
details regarding how we hold your data is available within our
Privacy Notice accessible

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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Please Provide a Cover in the English Language.
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