Chemical Manufacturing Engineer
Our client, a medical device company in Galway are currently looking to recruit a Chemical Manufacturing Engineer for their site.
- You will be responsible for researching and developing new and improved chemical manufacturing processes. Manufacturing line products, processes, equipment, and documentation to meet quality, service and cost objectives for AOP targets.
- Responsible for the installation, calibration and preventative maintenance of process equipment.
- You will provide technical support in field related activities such as clinical programs and complaint investigations.
- You will liaise with other plants regarding technical issues.
- You will undertake specific projects as designated in support of the business unit objectives.
- You will contribute to and give technical support to required site visitor programs as required.
- You will demonstrate your ability to identify continuous improvement activities & lead or participate in cross-functional teams through implementation, qualification & validation.
- This will include cost reduction, process efficiency & operational excellence.
- You will have the ability to monitor and improve chemical processes with respect to cycle times, machine utilization and yields.
- You will structure experiments for coating/impregnation processes, material performance improvements and develop new chemical processes for new products.
- You will lead and support root because driven approaches to problem solving efforts for chemical issues.
- You will analyse and report on chemical, quality and technical issues within Manufacturing Departments.
- You will provide expertise to support product development cycles, technology transfers and Operations scale ups.
- You will perform laboratory studies of steps in manufacture of new product and test proposed process in small scale operation.
- You will prepare / critically review protocols / reports and co-ordinate qualification and validation activities in conjunction with Engineering / Quality team, providing expert chemical direction as appropriate
- You will maintain expert up to date knowledge of developments in regulatory compliance requirements for product de-sign, development, transfer and commercialization activities.
- We are looking for a qualified person to third level 8 Degree/ Masters in Chemical Engineering/ Process Engineering or related discipline with relevant experience in the pharma/chemical synthesis industry
- You will have 5 years relevant manufacturing experience in pharma industry (ideally API related)
- You will have knowledge of Analytical test methods and Regulatory requirements (i.e. FDA/BSI Audits)
- You will demonstrate experience with and effective application of Validation Protocol and Report creation, Equipment and Process Validations (IQ, OQ, PQ, and PV), GD&T, MSA, DOE's, Design and Process FMEA's, SPC, Process Control Plans, Gauging applications, design, and construction, sampling methodologies, data analysis.
- You are a dynamic team player and can work effectively and proactively on cross-functional teams.
- You are experienced with process/product development, ideally in medical device industry and knowledge of process optimization, qualification and validation techniques.
- You will have broad knowledge of materials and processes applicable to medical device industry is desirable.
- You will have experience of medical device industry regulations, manufacturing engineering role and ability to manage self and others to achieve challenging targets is advantageous.
- You can demonstrate the following leadership expectations; Sets High Standards for other, Drives Accountability, Initiates & Leads Change and Thinks Critically & Makes Sound Decisions. You are a good communicator and fluent in English, both in writing and speaking.
- You will have experience with API & Solvents, with chemical processing, handling & manufacturing.
- You will have owned manufacturing processes & design previously and optimization these processes to sustain & improve product quality, yields & throughput.
- You will have strong written and verbal communication skills and basic PC skills (MS Word, Excel, PowerPoint, MS Project, etc.)
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