Senior Equipment Design Engineer, Combination Products
|Job Title:||Senior Equipment Design Engineer, Combination Products|
|Job Published:||8 months ago|
Our client, a young innovative company with strong investment, now seeks a highly skilled and experienced Equipment Engineer at Senior level, who will support development of proprietary combination products. This is a hybrid permanent role, requiring Dublin office presence one day per week.
Reporting to the Director of Product Development and working closely with the CMC team, this hire’s key responsibilities include manufacturing technology selection, bespoke equipment specification, build, commissioning, validation and scale-up for commercialization. A key component of this role with require expertise with drug product equipment engineering, from start to finish (i.e., URS to PQ validations, etc.).
Through management and technical oversight of external development partners, the Equipment Engineer will be focused on ensuring that the manufacturing equipment requirements are accurately defined and aligned with the device and drug product manufacturing process, followed by development of robust manufacturing solutions to deliver quality product to market.
Responsibilities of Senior Equipment Engineer:
Design and develop manufacturing equipment for Fill, Assembly and Packaging lines.
Lead development of User Requirement Specifications and equipment & technology selection.
Coordination of manufacturing equipment design with other disciplines and equipment suppliers.
Specify suitable manufacturing equipment for various stakeholder needs – from low volume GMP batches to high volume commercial product.
Support vendor evaluation and selection process.
Manage/support external manufacturing operations during manufacturing process development, scale-up, and technology transfer.
Lead technical root cause analysis, incident investigations and troubleshooting issues related to equipment and device manufacturing process.
Development, review and approval of Validation Plans, QRAES, URS, FAT, SATs, IQ, OQ and PQs etc. for process equipment and device manufacture in line with GMPs, regulatory requirements, and the company standards.
Oversee the development and implementation of appropriate documentation, and process work instructions compliant with current Good Manufacturing Practices (GMP).
Identify, develop and implement process improvement initiatives to optimize efficiency, reduce waste, and minimize costs.
Support risk assessments and develop mitigation plans for manufacturing processes (e.g., pFMEAs).
Support supply chain optimisation and product cost reduction initiatives.
Maintain knowledge of regulatory requirements, industry trends, and emerging technologies related to pharmaceutical manufacturing.
Support DFMA reviews of the combination product to optimise manufacturability.
Identify opportunities to improve process and equipment reliability, repeatability, compliance and consistency.
Identify and own KPI’s for various manufacturing process areas.
Project planning, in support of major projects and process transfers.
Support the authoring and implementation of SOPs in compliance to the relevant global standards for pharmaceutical and medical device manufacturing.
Support supplier qualification, including contract manufacturers and test facilities associated with manufacturing.
Requirements for Senior Equipment Engineer:
Bachelors or Masters qualification in Engineering, Science or related field.
5+ years related experience in medical device and/or pharma manufacturing process and equipment development.
Experience with cGMP, EMA and FDA regulations, and other regulatory requirements.
CQV experience is an advantage.
Proven knowledge of the relevant regulations for inhalation medical devices and combination products desirable.
Previous experience in regulatory inspections is desirable.
Experience interacting with third party service providers required.
Acute attention to detail supported by the ability to see the big picture.
Strong organizational, planning, problem-solving, analytical and decision-making skills.
Focused on making data driven decisions, process control, continuous improvement and operational excellence.
Experience in Six Sigma and Lean methodologies are an advantage.
Proven experience in successfully achieve results within globally diverse, cross-functional team.
Self-motivated with the ability to work in a fast-paced environment.
Creative, flexible, and innovative team player.
Effective communication skills (both written and verbal).
Strong organizational skills and attention to detail.
Please phone Larry on +353 1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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