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Client Representative,
for US based Pharmaceutical Company building a new facility
in Ireland, during the Software Factory Acceptance Test
of DeltaV Control System |
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Management of test resource and test allocation. Responsible
for the daily progress of all SFATs. Review and approval of
all faults with the supplier ensuring all testing complies
with approved validation protocols and specifications. Facilitate
the close out of all faults and issues arising from the execution
of the SFAT. |
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DCS Validation Consultancy for a Major Pharmaceutical
Manufacturer. |
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Validation consultant for a S88 Batch DeltaV Control System.
This site operated to cGDP, cGMP and FDA regulations for the
supply of pharmaceuticals. The main thrust of the work undertaken
was to write, execute and review OQ protocols as well as undertaking
remediation work to close test exceptions. |
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Applications Engineering for major system supplier
involving the development of a Batch Control system for pharmaceutical
manufacturers using DeltaV. |
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Developing, documenting and testing of class generics; developing,
documenting, configuration, test specification and testing
for S88 batch plant, including control modules, equipment
modules, phases, units etc. Wireless Bar code reader software
development, documentation, test specifications and testing.
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Project Managing the supply of PCS/ESD batch system
to a International Pharmaceutical Company. |
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Fast track project with significant changes in process design
throughout the project life, requiring effective management
of change control and good relationship with both contractor
and end user. PCS/ESD contract comprised design, configuration
and testing of Hardware and Software complying with cGMP and
FDA. Responsible for PCS/ESD system validation for all stages
up to Installation Qualification. Unique project challenges
included contractor/customer imposing a revised implementation
strategy part way through the project, changing from ASTRID
to S88 as well as increasing project scope. Scope changes
and cost control required significant management and justification.
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Responsible for the design, procurement and installation
of a Yokogawa Distributed Control System in the Tablet Manufacturing
Stream for a major Pharmaceutical Manufacturer's Operations
division. |
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The system is dual redundant providing full control from PC
terminals. Initially replacing outdated PLC controls in the
Granulation Suites the system is designed for application
to the other Tablet Manufacturing processes. Validation to
GAMP. |
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The Design/Decoding of an operational Batch Chemical
plant making emulsion for photographic film. |
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Various stages of the project covered: Decoding of Kent K90/P4000
PROSEL and BASIC software and working with the client on how
the software could be implemented on an I/A system; Advising
on methods of Scheduling, Reporting and Operator actions for
plant control; Conversion of Kent data block data and advising/building
Foxboro database blocks; Design of Batch Control software
structure and creation of Batch Control Recipes. |
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Development and implementation of software to automate
Cleaning and Start-up required as part of new manufacturing
system for International Pharmaceutical Company. |
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Working closely with the customer, designed software, implemented
and commissioned within production schedules of the plant.
System consisted of K90 and code written in PROSEL. |
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The periodic re-validation of software and documentation
to meet FDA regulations for International Pharmaceutical Company.
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An IBM PC Data logging package was upgraded to include Microsoft
Windows, with conversion of software to Clipper and Xtalk
to facilitate these audits. |
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Consultancy to produce the requirements for new
pharmaceuticals plant based on information collected over
a six month period at the parent company site in the USA.
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Production of a full User Requirements Specification, followed
by a detailed Implementation Specification for the selected
DCS vendor. This was followed by software implementation,
with responsibilities for on time delivery of quality software,
followed by site commissioning. All development and testing
to GAMP. |
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Automation of manual chemical cleaning routines,
Optimising processes (to reduce plant failure and cycle time)
and assisting with the introduction of new and variations
on existing products (including the provision of new and/or
modified software) for a Major Pharmaceutical Manufacturer.
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Following the control system replacement, the opportunity
was taken eliminate non-critical alarms and improve control
processor loading. |
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The development of a modular prototype system based
on S88, 15 Allen Bradley PLC’s and a SETCIM SCADA system.
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Technical software design and implementation to FDA validatory
requirements, from a requirements specification, utilizing
a team of seven engineers. Designed and implemented interfaces
to an MES and PLC controlled vendor packages. Also responsible
for writing the functional design specification and the software
design specification Management of the software team and ensuring
that configuration standards are consistent throughout the
design and implementation. |
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For a Major Primary Pharmaceutical Manufacturer,
performed FDA Compliant Validation of Legacy systems. |
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Produced a report with recommendations and other safety related
matters. Reviewed existing procedures and making recommendations
producing validation plan and test scripts for Varian PHLC,
Vertis freeze dryer and Trend 945 HVAC, this involved reviewing
Intellution FIX32 application, Siemens and Allen Bradley PLC
code and Trend IQ250 strategy as well as OPC links to Excel
spreadsheets. |
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A BMS Package Manager responsible for the Design,
Manage, Construct project developing a Pharmaceutical Technology
facility for a Major Pharmaceutical Manufacturer. |
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Half of the installed system was to be validated to GMP standards
to satisfy both the Medicines Control Agency in the UK and
the FDA in the USA. To achieve this it was necessary to develop
special QA procedures and to adopt structured programming
techniques, in addition to the production of the qualification
protocols. |
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Representing Major Pharmaceutical Manufacturer for
the computer automation aspects of infrastructure development.
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Establish procedures, standards and policies for control and
instrumentation systems, liaison with client user groups and
external agencies to establish the requirements for central
monitoring and site-wide networking of: Engineering systems
for building management and process control applications;
office data and communication systems; safety systems (fire
detection/prevention and security). Preparation of employer’s
briefs for tender invitation, and the subsequent vetting of
bids received for design and implementation contracts. Monitoring
and co-ordination of the appointed contractors for the energy
centre and site services projects, ensuring adherence to client
requirements, standards and policies and the procurement of
cost-effective quality systems, with a strong emphasis placed
on the adherence to STARTS guidelines and procedures. Liaison
with local authorities concerning the provision of telemetry
based systems for control and monitoring of drainage facilities.
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