Job Details: QA Validation Engineer


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
QA Validation Engineer
1. Prepare periodic validation review documentation for approval by
the business units.

2. Maintain site validation registry.

3. Ensure validation activities completed comply with US and EU
relations, GBSC procedures and EHS requirements.

4. Review and approve documents prepared by project teams, other
departments and contractor organizations (e.g. protocols, reports,
change controls)

5. Assist in development of validation strategy and validation plan
for equipment and process validations.

6. Assist in the development of sampling plans, test plans and data
analysis related to process validation.

7. Assist in resolution of deviations/ exceptions during qualification
activities

8. Assist with change control activities in accordance with site
procedures

9. Attend identified training, required to fulfil the role of QA
Validation Engineer

**Apply on the website**. Support the QA Validation team leader in
driving improvements within the Validation and Change Control
processes to streamline the validation activities associated with
Process Changes, Product Transfers and/or New Product Introductions.

**Apply on the website**. Participate in cross-functional teams as
required.

EXPERIENCE ESSENTIAL:

* Hons. Degree Quality/ Manufacturing / Engineering / Science

* Minimum of 2 years&#**Apply on the website**; experience in Quality
Assurance/Engineering

* Minimum of 1 years&#**Apply on the website**; experience in Process,
Equipment and Test Method Validation

* Working knowledge of Quality systems (FDA/ISO) within a regulated
environment

* Ability to analyze Capability data using MINITAB

* Ability to interpret Engineering drawings/specifications

* Familiarity in areas of various inspection techniques

* Excellent interpersonal & communication skills

DESIRABLE:

* In depth knowledge of **Apply on the website** CFR **Apply on the
website**, **Apply on the website** CFR **Apply on the website**, ISO
**Apply on the website** and European regulations associated with the
medical device industry

* High understanding of GMP, Compliance, Validation practices
including the system development life cycle and regulatory
expectations

Our role in supporting diversity and inclusion

As an international workforce business, we are committed to sourcing
personnel that reflects the diversity and values of our client base
but also that of Orion Group. We welcome the wide range of experiences
and viewpoints that potential workers bring to our business and our
clients, including those based on nationality, gender, culture,
educational and professional backgrounds, race, ethnicity, sexual
orientation, gender identity and expression, disability, and age
differences, job classification and religion. In our inclusive
workplace, regardless of your employment status as staff or contract,
everyone is assured the right of equitable, fair and respectful
treatment 1. Prepare periodic validation review documentation for approval by
the business units.

2. Maintain site validation registry.

3. Ensure validation activities completed comply with US and EU
relations, GBSC procedures and EHS requirements.

4. Review and approve documents prepared by project teams, other
departments and contractor organizations (e.g. protocols, reports,
change controls)

5. Assist in development of validation strategy and validation plan
for equipment and process validations.

6. Assist in the development of sampling plans, test plans and data
analysis related to process validation.

7. Assist in resolution of deviations/ exceptions during qualification
activities

8. Assist with change control activities in accordance with site
procedures

9. Attend identified training, required to fulfil the role of QA
Validation Engineer

**Apply on the website**. Support the QA Validation team leader in
driving improvements within the Validation and Change Control
processes to streamline the validation activities associated with
Process Changes, Product Transfers and/or New Product Introductions.

**Apply on the website**. Participate in cross-functional teams as
required.

EXPERIENCE ESSENTIAL:

* Hons. Degree Quality/ Manufacturing / Engineering / Science

* Minimum of 2 years&#**Apply on the website**; experience in Quality
Assurance/Engineering

* Minimum of 1 years&#**Apply on the website**; experience in Process,
Equipment and Test Method Validation

* Working knowledge of Quality systems (FDA/ISO) within a regulated
environment

* Ability to analyze Capability data using MINITAB

* Ability to interpret Engineering drawings/specifications

* Familiarity in areas of various inspection techniques

* Excellent interpersonal & communication skills

DESIRABLE:

* In depth knowledge of **Apply on the website** CFR **Apply on the
website**, **Apply on the website** CFR **Apply on the website**, ISO
**Apply on the website** and European regulations associated with the
medical device industry

* High understanding of GMP, Compliance, Validation practices
including the system development life cycle and regulatory
expectations

Our role in supporting diversity and inclusion

As an international workforce business, we are committed to sourcing
personnel that reflects the diversity and values of our client base
but also that of Orion Group. We welcome the wide range of experiences
and viewpoints that potential workers bring to our business and our
clients, including those based on nationality, gender, culture,
educational and professional backgrounds, race, ethnicity, sexual
orientation, gender identity and expression, disability, and age
differences, job classification and religion. In our inclusive
workplace, regardless of your employment status as staff or contract,
everyone is assured the right of equitable, fair and respectful
treatment

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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