CSV Engineer

Recruiter
Optimus Life Sciences
Location
Camberley
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Contract
Hours
Full Time
Are you a CSV Engineer interested in working for one of the Uk's leading names in High-Tech Pharmaceutical Equipment Engineering?
Are you looking for something new?!
Then stop what you are doing and read on!

Title: CSV Engineer

Rate: Negotiable

Location: Surrey - Camberley

Type: Contract (6 Months)

A Fantastic new role has just opened up at one of our leading Surrey based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

Responsibilities include:

* Carry out assignments in terms of compliance projects, commissioning and validation activities associated with automated/computerised systems.
* Interpret technical requirements and produces test protocols for automated/computerised systems (including hardware, software, and network components), and controlled functions and processes, undertakes physical evaluation tests on those systems, interprets data and produces technical reports.
* Support the implementation of automation projects and associated commissioning or validation activities.

* Interprets automated/computerised system requirements in order to recommend appropriate system/vendor selection
* Review, and/or, prepare technical or lifecycle documentation associated with automated/computerised systems
* Interprets regulatory requirements and proposes test methodologies for commissioning or computer validation activities
* Prepares and executes test protocols for automated systems to evaluate conformance and performance against pre-determined acceptance criteria
* Analyses test results against acceptance criteria and prepares summary reports
* Makes recommendations to the clients project teams for any remedial actions where acceptance criteria are not met.
* May supervise engineers and technicians, or act as client witness for test work performed by equipment vendors and sub-contractors.
* Manages automated/computerised system project programme activities and costs

Key Activities

* Undertakes technical evaluation of the clients and regulatory requirements for automated/computerised systems
* Evaluates systems and equipment to identify key performance requirements
* Develops technical documentation to test and assess performance
* Undertakes physical evaluations and testing, interprets results and makes acceptance or rejection recommendations
* Project Manages commissioning and validation activities

Requirements

* Knowledge of computer validation lifecycle documentation, processes and principles

* Knowledge of commissioning processes
* Knowledge of control and IT systems
* Experience of GMP working processes and GAMP
* Knowledge of FDA and European standards
* Experience of production or control and instrumentation engineering
* Experience of instrumentation/field panels, PLCs or SCADA systems
* Experience of instrument verification, and configuration and software management
* Experience of site test and inspection plans
* Knowledge of Quality Systems
* Experience of pharmaceutical or other process equipment
* Focus on environment, health and safety issues

If you are interested please do not hesitate to email or call me!

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