Lead Process Engineer - API
|Job Title:||Lead Process Engineer - API|
|Contact Name:||John Reid|
|Job Published:||over 1 year ago|
My client a growing Healthcare Manufacturing company now require an experienced Lead Process Engineer - API to join their expanding team.
This is a permanent role based in The Midlands commutable from parts of both Dublin and Galway and it comes with a very good salary with good benefits with great potential opportunities.
Responsibilities of Lead Process Engineer - API
Works with manufacturing and quality colleagues as part of an Operations team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
Prioritises safety and is diligent in the use of all appropriate safety tools and permits when maintaining equipment - champions safe working always.
Will program manage and technically lead receiving site activities necessary for the successful transfer of new products onto the site via a structured and compliant NPI (new product introduction) process.
Will prepare site process descriptions by developing a PCS (process control strategy) for the processes and in identifying and agreed with Quality the process CPPs (Critical Process Attributes) and CQA (Critical Quality Attributes) for products.
Provides technical support for product PPRs (Periodic Product Review)
Is the process SME for the compounding process and supports manufacturing and maintenance in the operation and maintenance of these systems.
Supports manufacturing by leading/supporting deviation investigations, and is familiar with structured problem solving and root cause analysis
Supports validation activity in process manufacturing areas.
Leads continuous improvement projects and initiatives and is owner of yield performance and cycle time improvement.
Provides training and mentoring to build technical capabilities among teams.
Supports capital projects throughout equipment lifecycle.
Requirements of Lead Process Engineer - API
At least 8 years relevant experience in a pharmaceutical manufacturing environment, with at least 5 years' experience in a comparable process engineering/technical services role.
Bachelor's Degree in Engineering (ideally chemical), Pharmaceutical Sciences, or related Science discipline.
Strong technical knowledge of bulk API production
Technical knowledge of OELs and product containment
Experience with ATEX and Ex rated equipment a plus
Technical knowledge of aseptic manufacturing techniques, procedures and theory a plus.
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below
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