Chemist/Project Manager

****-******* ********** ******** *********** (UK)

Follow validation policies, procedures and guidelines on behalf of BioReliance UK so that business critical equipment, instruments, systems, and processes comply with current GxP standards.

Ensure that relevant equipment is appropriately validated, in accordance with the current Validation Master Plan, following the appropriate approved protocols.

Ensure that scheduled routine validation activities are adequately carried out so that business critical equipment, instruments, and systems remain fit-for-purpose.

Perform validation risk assessments for critical equipment, instruments, systems, and processes.

Ensure that validation risk assessments are created for all relevant equipment, in accordance with the current Validation Master Plan, and that risk assessments are review periodically (determined by agreed schedule which must be documented in the BioReliance inventory management system (Calibration Manager).

Contribute to the design of validation studies for critical equipment, instruments, systems, and processes, which will include the creation of new validation protocols and/ or the review of existing protocols.

Ensure that appropriate records of all validation activities are completed, approved (as required) and filed to effectively maintain business critical equipment, instruments, and system histories.

Ensure that all test equipment/ standards used to perform validation activities are appropriately calibrated and certified before use.

Ensure that all business critical equipment, instruments, and systems are accurately labelled to identify the asset and identify engineering activities performed and compliance status, e.g., due date, where applicable.

Liaise with BioReliance UK operational departments to ensure equipment is validated with minimum disruption to operations and is made available within agreed timelines.

Co-ordinate with external contractor activities in support of validation, as required. Such activities may include (but are not limited to) facilitating equipment, instrument, system access; reviewing/ verifying and approving the adequacy of contractor work and documentation.

2006-2008 MAINTENANCE TECHNICIAN Bioreliance (UK)

Controlled the operation of a GMP area of a highly protocol and sophisticated

Medical research environment of machines in a clean room environment to ensure down time was kept to a minimum.

Written and implemented training, maintenance, validation and calibration procedures.

Calibrated, validated, installed, repaired and serviced the following equipment fridges, freezers, incubators (general and CO2), autoclaves and centrifuges scheduled and un-scheduled with a computerised maintenance database software.

Diagnosed and corrected faults and liaised with management on major defects to maintain efficiency.

Experience to an expert level on data acquisition systems.

2004-2006 PRODUCT ENGINEERING ATMEL (UK)

Working in the Product Engineering department I support Manufacturing and Maintenance Technicians, Manufacturing and Product engineering and shift operations Manager.

Disposition HOLD lots, improve cycle time of their shift, and own all aspects of quality performance of their shift.

Working closely with planning and customers to ensure accurate and timely processing of project and external sales wafers, including special requests and experiments.

2003-2004 MANUFACTURING ENGINEERING ATMEL (UK)

Working in the Manufacturing Engineering department I would set up and maintain wafer probe and test equipment that test electrical properties of circuits on semiconductor wafers, following set-up manual specifications: Reads process sheet and set-up manual to determine test program required and set-up specifications. Activates test equipment to make trial run to ensure correct equipment set-up and informs equipment operator that set-up is completed. Replaces defective probes or probe cards and solders joints on replacement probes, using soldering iron. Tests electrical continuity of cable connecting wafer probe and test equipment, using ohmmeter. Replaces defective connector cables.

2002-2003 ETCH PROCESS RETRONIX (UK)

Operate machine for process of wafers, test and inspect.

Calibrate machine for quality of etch of wafer.

2000-2002 MAINTENANCE NEC Semiconductors (UK)

Controlled the operation of an area of highly automated and sophisticated

Process machines in a clean room environment to ensure down time was kept to a minimum.

Experienced of faultfinding and maintenance of mechanical, pneumatic, electrical and electronic components.

Analysed data on machine errors, devised modification and improvements to the process and presented findings to management.

Diagnosed and corrected faults and liaised with management on major defects to maintain efficiency.

1999-2000 ADMINISTRATOR Rolls-Royce ENG.

Input data on labour and parts cost to SAP system and reported results to senior management.

1998-2000 CUSTOMER SERVICE STEWARD MECCA BINGO.

Interacted with customers, handled cash.

QUALIFICATIONS-

16TH Edition Electrical Wiring Glasgow college 2008

Breathing apparatus Certified Sabre sigma 2 S.C.B.A 2007

Portable appliance testing Certified 2007

ECDL QUALIFIED Learndirect 2002

Microsoft Packages.

BACHELOR OF TECHNOLOGY Degree. Strathclyde university 2000

Electrical and Electronic Engineering.

HND Bell college 1998

Electrical and Electronic Engineering.

Higher Grade (Maths and Physics) Larkhall Academy 1995

Standard Grade (Maths, Physics, English, Chemistry, Technological and Art Design).

Larkhall Academy 1993

Computer skills: Highly competent frequent user of Microsoft Word, Excell

and Power point.

NEC trained in company practices and machine maintenance.

INTERESTS

Swimming, watching films and socialising with family.

PERSONAL DOB: 09/02/78 Married Non-smoker Full clean driven license.

JAMES WALSH

21 Green Oakhill Gate E-MAIL : HYPERLINK "mailto:*****.*.*****@********.***" *****.*.*****@********.***

Uddingston Mob TEL:075********

Lanarkshire

G71 7PR

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