recent relevant experience in a process engineering role in the
Pharma/Chemical/Biotech industry?
This is a contract role and can be based in Cork or Dublin.
If interested, please send your CV to karen@jobcontax.com or
call Karen on + *- *
LEAD PROCESS ENGINEER - BIOTECH PLANT - CORK
JOB DESCRIPTION
Our client is a leading international engineering consultancy.
The successful candidate must have strong leadership and planning
qualities, be adaptable to change and be comfortable working cross
functional design and production teams delivering to strict deadlines
and budgets.
Pharmaceutical process knowledge, equipment specification development
and understanding of validation is required.
Leading and Managing the Process Design for Small Molecule API
projects for the introduction of new products, equipment, and
processes to meet all safety, quality, regulatory and operational
requirements.
Also includes Leading the Process Design on non-production projects,
such as Utilities, Tanks Farms, Incinerators and Waste Water Treatment
plants.
Supporting Process development (as part of technical transfer),
troubleshooting and optimisation.
Development of process estimates, including equipment costs.
Working with a cross functional Design team to ensure accurate
completion of Detailed Design, on time and on budget
Working with a cross functional team as part of project planning and
deployment; including collaboration with supporting departments such
as Technical Development, Production/Operations, Quality, Safety,
Facilities and Engineering.
Process mapping, gap analysis/identification for new and existing
pharmaceutical manufacturing processes.
Equipment specification, process design, commissioning (if required)
and as building
Development and Management of the Change Control for the Project using
the Client’s Trackwise system.
Co-ordinating design changes using the Client approved change control
procedure to ensure that cGMP is adhered to.
Generation, review and approval of project documentation (Scope, User
Requirement Specifications etc)
Supervision of Junior Process Engineers if specific project requires
additional support
Support validation activities for project activities including review
of validation documentation and attendance at validation activities as
required (FAT, IQ, OQ etc).
To ensure that all new equipment is bought in accordance with
appropriate site procedures & regulations.
To provide technical support to system end users of new and existing
equipment including but not limited to troubleshooting technical
issues and assisting with process investigations.
To facilitate and participate in meetings and workshops as part of
Projects and Continuous Improvement activities.
Hazop attendance and management of the closeout of the Hazop
Recommendations
Update existing Hazardous Area reports for Equipment/Process
Provide technical updates to Standard Operating Procedures (SOPs)
related to the equipment/process changes
To adhere fully to all safety policies, procedures and regulations.
To participate in all training and assessment activities related to
the role.
To perform all activities in accordance with current Good
Manufacturing Practice.
To record and report any Process changes relating to the projects,
which could impact budget and schedule
To create, review and approve Site Engineering Specifications and
other documents as required, ensuring the acceptability of content and
format.
REQUIREMENTS
B.Eng in Chemical and Processing Engineering or appropriate science or
engineering discipline.
A minimum of *+ years’ recent relevant
experience in a process engineering role in the
Pharma/Chemical/Biotech industry.
Pharmaceutical Manufacturing Process understanding and experience e.g.
reactors, filter dryers, solvents, powder charging and powder
discharging.
A proven track record in process design, development, support and
improvement is required.
A good understanding of ATEX and Hazardous Area Zoning
The ability to organise, plan and execute multiple tasks to tight
schedules
Flexibility and ability to adapt to changing priorities is required.
Proven track record of process-based activities in the pharmaceutical
industry.
Experience with process technologies.
Experience with process equipment procurement.
Good communication skills combined with an imaginative and creative
approach to problem solving.
Strong leadership skills and the ability to work in cross-functional
team environments, as well as independently.
PACKAGE
Hourly Contract rate Negotiable based on experience
We need : English (Good)
Type: Permanent
Payment: Negotiable
Category: Construction
