Featured Advertisers

emc2 apple atlanco pharmeng teamworx dell



This job has been removed from the site. Here are the details which were advertised.


            View Similar Jobs
            View other jobs from this advertiser


MANUFACTURING VALIDATION ENGINEER

 

Company:

LOTUS TECHNICAL SERVICES
Apply for this job

Job Reference Number

14565282

Client ID:

RI/LTS MVE C
Add to Job Basket

Posted On:

Feb 3 2012

Location:

CORK
Mail a Friend

Job Type:

Contract

Salary:

COMPETITIVE
Print this job
Lotus Technical Services is a leading solutions provider offering a complete range of automation and technical services specifically designed to enhance productivity and efficiency, and to maximise the value of our customer's core business. We are currently recruiting a Manufacturing Engineer based in Cork.

Job Purpose:

The purpose of this role is to support the validation of CIP processes to GAMP/FDA standards, and provide additional support to other projects as required. You will report to the Team Leader.

Responsibilities:

· Continuous Improvement Focus

· Generate and review validation documents (URS, RA, FDS, VP, IQ’s, OQ’s & PQ’s)

· Execute validation protocols and generate reports and ensure they are completed in accordance with procedure and cGMP’s.

· Participate in performance of Risk Assessments.

· Participate in the design of FMEAs and prepare executive summary reports for FDA submissions.

· Collaborate with Engineering, Operations and Quality in the execution of the protocols.

· Support manufacturing as the Quality Engineer line support for technical & quality issues.

· Oversee the specification, completion, and reporting of all internal and external analytical testing required by validation protocols.

· Establishment of solution testing procedures to be used in production.

· Ensured that all data, results & information associated with qualification and validation activities are recorded accurately, completely and in accordance with the company procedures.

· Resolve any deviations associated with protocol execution

· Ensure adherence to site procedures and industry practice e.g. GAMP.

· Strong project management skills in delivering projects on time and on budget.

· Oversee tracking process for project implementation against baseline plan.

· Influencing and persuading key project participants and maintaining their motivation.

Requirements

· The successful candidate will have a 3rd Level Degree qualification in a Mechanical/Science Discipline with several years scientific / analytical testing or related experience.

· Relevant experience of the Orthopaedic industry and the associated regulatory requirements would be an advantage.

Lotus Technical Services is an Equal Opportunities Employer