TULLAMORE Project Engineering group on plant projects and plant
initiatives to improve process capabilities. The role will incorporate
site validation activities as the site Validation Subject Matter
Expert supporting process and projects activities.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
* Leading a group of Project Engineers in the execution of corporate
projects in accordance to sites Project Management Process meeting
scope, cost, and time requirements.
* Managing the site&#**Apply on the website**;s project portfolio
reporting out to the Site Management team.
* Accountable for the disciplined implementation of Project
Management tools and best practices.
* Site Validation SME with specific expertise and responsibilities
for validations to include defining validation policy, ownership, and
administration of site validation procedure, verification of
conformance to policy, resolving validation disputes, and
non-conformance resolution.
* Manage, mentor, and develop Project Engineers and Validation Team
to meeting site requirements.
* Key stakeholder providing validation input on project planning.
* Support the various engineering groups in process characterization
and optimization.
* Trending and analysis of site validations to meet regulatory,
compliance and performance requirements.
* Managing the site project and validation performance KPI&#**Apply
on the website**;s, MVP and project portfolio.
* Support site Process Engineers in validation activities.
* Drive continuous improvement within various Engineering and
Validation practices.
* Present and defend validation approaches and results to all
external and corporate auditors.
* Actively participate in and support company and plant wide
initiatives including six-sigma, lean, safety and cost reduction.
* Assist in the maintenance of a safe company culture by working
within the company&#**Apply on the website**;s health and safety
guidelines at all times and reporting any equipment or process
problems in line with plant escalation procedures
* Identify continuous improvements opportunities where possible and
take part in improvement projects as assigned.
* Carry out additional duties that may be assigned to you.
QUALIFICATIONS & EXPERIENCE
* A degree in Engineering / Technical discipline or equivalent
experience.
* A minimum of 8 years&#**Apply on the website**; experience working
in the medical device industry with focus on project management,
validation activities and process capability
* People management experience
* PMP or Prince2 qualification
* Audit facing experience with FDA and Notified Bodies essential
* Proficient in Minitab and data analysis
* A Six-Sigma certification is desirable but not essential
SKILLS & COMPETENCIES REQUIRED
* Experience of working within a regulated industry with knowledge of
MDD (Medical Device Directive), ISO **Apply on the website** (Quality
Management Systems), FDA, cGMP, and Risk Management (ISO **Apply on
the website**)
* Experience in a supervisory or leadership role with people
management responsibility
* Ability to work with cross-functional teams, including production,
quality, engineering and materials.
* Experience working with moulding and extrusion processes and with
automated assembly processes is desirable.
* Ability to multi-task and to work in a high paced environment with
an awareness of continued impact on production and the plant
performance.
* Organised and resourceful with excellent attention to detail and
ability to get the job done
* Clear written and verbal communication skills
* Energy and self-motivation.
* The ability to focus on problem resolution in the plant.
* The ability to take responsibility for their own professional
development and implement new approaches to doing things. Focused on
simplicity of implementation.
* An excellent record of attendance and time keeping
* Commitment to work within the ethos of the company Mission,
Medical Devices & Supplies Guide to Compliance and Quality
Manufacturing and The Standards of Business Conduct
Kelly Services are acting as an Employment Agency in relation to this
role. Should you choose to apply, your information will be processed
in accordance with Kelly&#**Apply on the website**;s Privacy
Statement.
As an Equal Opportunities employer we welcome applications from all
suitably qualified persons regardless of their race, sex, disability,
religion/belief, sexual orientation or age.
The ENGINEERING SUPERVISOR will be responsible for the supervision of
TULLAMORE Project Engineering group on plant projects and plant
initiatives to improve process capabilities. The role will incorporate
site validation activities as the site Validation Subject Matter
Expert supporting process and projects activities.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
* Leading a group of Project Engineers in the execution of corporate
projects in accordance to sites Project Management Process meeting
scope, cost, and time requirements.
* Managing the site&#**Apply on the website**;s project portfolio
reporting out to the Site Management team.
* Accountable for the disciplined implementation of Project
Management tools and best practices.
* Site Validation SME with specific expertise and responsibilities
for validations to include defining validation policy, ownership, and
administration of site validation procedure, verification of
conformance to policy, resolving validation disputes, and
non-conformance resolution.
* Manage, mentor, and develop Project Engineers and Validation Team
to meeting site requirements.
* Key stakeholder providing validation input on project planning.
* Support the various engineering groups in process characterization
and optimization.
* Trending and analysis of site validations to meet regulatory,
compliance and performance requirements.
* Managing the site project and validation performance KPI&#**Apply
on the website**;s, MVP and project portfolio.
* Support site Process Engineers in validation activities.
* Drive continuous improvement within various Engineering and
Validation practices.
* Present and defend validation approaches and results to all
external and corporate auditors.
* Actively participate in and support company and plant wide
initiatives including six-sigma, lean, safety and cost reduction.
* Assist in the maintenance of a safe company culture by working
within the company&#**Apply on the website**;s health and safety
guidelines at all times and reporting any equipment or process
problems in line with plant escalation procedures
* Identify continuous improvements opportunities where possible and
take part in improvement projects as assigned.
* Carry out additional duties that may be assigned to you.
QUALIFICATIONS & EXPERIENCE
* A degree in Engineering / Technical discipline or equivalent
experience.
* A minimum of 8 years&#**Apply on the website**; experience working
in the medical device industry with focus on project management,
validation activities and process capability
* People management experience
* PMP or Prince2 qualification
* Audit facing experience with FDA and Notified Bodies essential
* Proficient in Minitab and data analysis
* A Six-Sigma certification is desirable but not essential
SKILLS & COMPETENCIES REQUIRED
* Experience of working within a regulated industry with knowledge of
MDD (Medical Device Directive), ISO **Apply on the website** (Quality
Management Systems), FDA, cGMP, and Risk Management (ISO **Apply on
the website**)
* Experience in a supervisory or leadership role with people
management responsibility
* Ability to work with cross-functional teams, including production,
quality, engineering and materials.
* Experience working with moulding and extrusion processes and with
automated assembly processes is desirable.
* Ability to multi-task and to work in a high paced environment with
an awareness of continued impact on production and the plant
performance.
* Organised and resourceful with excellent attention to detail and
ability to get the job done
* Clear written and verbal communication skills
* Energy and self-motivation.
* The ability to focus on problem resolution in the plant.
* The ability to take responsibility for their own professional
development and implement new approaches to doing things. Focused on
simplicity of implementation.
* An excellent record of attendance and time keeping
* Commitment to work within the ethos of the company Mission,
Medical Devices & Supplies Guide to Compliance and Quality
Manufacturing and The Standards of Business Conduct
Kelly Services are acting as an Employment Agency in relation to this
role. Should you choose to apply, your information will be processed
in accordance with Kelly&#**Apply on the website**;s Privacy
Statement.
As an Equal Opportunities employer we welcome applications from all
suitably qualified persons regardless of their race, sex, disability,
religion/belief, sexual orientation or age.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
