Job Details: Laboratory Systems Business Consultant


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Laboratory Systems Business Consultant
About the Role:

Zenith Technologies have an immediate requirement for Laboratory
Systems Business Consultant. The successful candidate will work with
our local and global engineering teams to provide expertise in the
areas of Laboratory Systems, Laboratory Operations and Project
Management for our clients in the Biopharmaceutical sector.

Responsibilities:

The Laboratory Systems Business Consultant will be based in our Dublin
office. This position will have a significant involvement with
internal and external customers to ensure:

* Technical alignment between the business process requirements and
the Lab Systems technical design by defining, describing and
communicating design and participating in design reviews, input on
technical elements of the design to deliver a fully qualified, fit for
purpose Laboratory Systems.

* Ensure projects are executed in accordance with the approved plan,
and that all deliverables are prepared to meet the approved schedule,
and the deliverables meet the customer&#**Apply on the website**;s
quality standards

* Participate in the qualification of the Lab Systems as per project
plan covering all aspects of testing, commissioning, operational
readiness and operational support.

* Ensures the right technical prioritization on projects.

* Main point of contact with client.

Qualifications & Requirements:

* Graduate/post graduate degree in lifesciences/ chemistry/
pharmaceutical sciences/ Computer Science

* **Apply on the website**+ years&#**Apply on the website**;
experience in Pharmaceutical Laboratory Operations including at least
3 years in a management or supervisory role. Must have previous
experience implementing Laboratory Information Systems, enterprise
system deployment, operational excellence initiatives, equipment
qualification or method validation/method transfers. Additional
experience in lab design, lab set up, lab system upgrades or QA
advantageous.

* Technical:

* Experience configuring QC builds for LIMS and LES applications.
Specific requirement for a minimum of 3 years&#**Apply on the
website**; experience with Thermo Fisher Sample Manager LIMS(**Apply
on the website**X or higher), additional systems is an advantage

* Candidate must have experience in interfacing equipment with Lab
systems such as ELN, CDS, SDMS with LIMS

* Candidate must have experience using proprietary lab equipment
applications such as Empower, Chemstation, Chromeleon, Tiamo

* Candidate must have experience generating equipment lifecycle
documentation (URS, test specifications, summary reporting) supporting
equipment qualification

* Candidate must have an understanding of Data Integrity principles,
and knowledge of **Apply on the website**CFR part **Apply on the
website** and EU Annex **Apply on the website**

* Candidate must have experience managing and coordinating project
deliverables

* Candidate must have worked in GMP/GLP environment and have strong
knowledge of the requirements for these regulations.

* Consultancy experience

* Candidate must have "customer first" mind set

* Candidate must have experience using data to drive decision making
and improvement initiatives

* Candidate must have interest new technology, innovative and its
implementation to improve business practices

* Candidate must have experience in identifying and defining
stakeholder requirements

* Candidate must have experience implementing or adhering to clients
corporative directives

* Candidate must have proactive approach to issue resolution and
problem solving

* Candidate must be able to identify opportunities for process
improvements and translate those improvements into business
requirements

* Candidate must have good command of English and be an excellent
communicator

* Desirable Skills:

* Lean Labs or 6-Sigma

* Regulatory audit experience About the Role:

Zenith Technologies have an immediate requirement for Laboratory
Systems Business Consultant. The successful candidate will work with
our local and global engineering teams to provide expertise in the
areas of Laboratory Systems, Laboratory Operations and Project
Management for our clients in the Biopharmaceutical sector.

Responsibilities:

The Laboratory Systems Business Consultant will be based in our Dublin
office. This position will have a significant involvement with
internal and external customers to ensure:

* Technical alignment between the business process requirements and
the Lab Systems technical design by defining, describing and
communicating design and participating in design reviews, input on
technical elements of the design to deliver a fully qualified, fit for
purpose Laboratory Systems.

* Ensure projects are executed in accordance with the approved plan,
and that all deliverables are prepared to meet the approved schedule,
and the deliverables meet the customer&#**Apply on the website**;s
quality standards

* Participate in the qualification of the Lab Systems as per project
plan covering all aspects of testing, commissioning, operational
readiness and operational support.

* Ensures the right technical prioritization on projects.

* Main point of contact with client.

Qualifications & Requirements:

* Graduate/post graduate degree in lifesciences/ chemistry/
pharmaceutical sciences/ Computer Science

* **Apply on the website**+ years&#**Apply on the website**;
experience in Pharmaceutical Laboratory Operations including at least
3 years in a management or supervisory role. Must have previous
experience implementing Laboratory Information Systems, enterprise
system deployment, operational excellence initiatives, equipment
qualification or method validation/method transfers. Additional
experience in lab design, lab set up, lab system upgrades or QA
advantageous.

* Technical:

* Experience configuring QC builds for LIMS and LES applications.
Specific requirement for a minimum of 3 years&#**Apply on the
website**; experience with Thermo Fisher Sample Manager LIMS(**Apply
on the website**X or higher), additional systems is an advantage

* Candidate must have experience in interfacing equipment with Lab
systems such as ELN, CDS, SDMS with LIMS

* Candidate must have experience using proprietary lab equipment
applications such as Empower, Chemstation, Chromeleon, Tiamo

* Candidate must have experience generating equipment lifecycle
documentation (URS, test specifications, summary reporting) supporting
equipment qualification

* Candidate must have an understanding of Data Integrity principles,
and knowledge of **Apply on the website**CFR part **Apply on the
website** and EU Annex **Apply on the website**

* Candidate must have experience managing and coordinating project
deliverables

* Candidate must have worked in GMP/GLP environment and have strong
knowledge of the requirements for these regulations.

* Consultancy experience

* Candidate must have "customer first" mind set

* Candidate must have experience using data to drive decision making
and improvement initiatives

* Candidate must have interest new technology, innovative and its
implementation to improve business practices

* Candidate must have experience in identifying and defining
stakeholder requirements

* Candidate must have experience implementing or adhering to clients
corporative directives

* Candidate must have proactive approach to issue resolution and
problem solving

* Candidate must be able to identify opportunities for process
improvements and translate those improvements into business
requirements

* Candidate must have good command of English and be an excellent
communicator

* Desirable Skills:

* Lean Labs or 6-Sigma

* Regulatory audit experience

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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