Process Engineer - New Product Introduction (m/f/x)
Posted 16 days 13 hours ago by Solventum
Job Description:
3M Health Care is now Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You'll Make in this Role
As Process Engineer - New Product Introduction, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.
Here, you will make an impact by:
The Senior Project Engineer will provide technical leadership across various project related activities. A knowledge of the design, development, and validation of manufacturing technologies essential for the role. This role will focus particularly on supporting the project team in validation and SOP documentation preparation as well as change control requests. Collaborate with other departments to ensure requirements of Safety, Quality, Cost & Service are achieved.
Major Duties and Primary Responsibilities:
Provide engineering support for new equipment and process changes, ensuring that all activities are completed and documented in accordance with regulatory requirements.
Write and edit standard operating procedures, test methods, technical/validation reports, regulatory submissions, investigations, and other related documents (VP, IQ, OQ, URS, etc.)
Evaluate process layouts in terms of supporting new process integration while ensuring best utilization of floor space ensuring optimum process flow.
Support budgetary, scheduling, and project databases, and report regularly to project manager on progress as well as on problems that could significantly affect cost or schedule.
Development of appropriate supporting documentation, SOPs, PFMEA, Control Plans and process work instructions compliant with current Good Manufacturing Practices (GMP).
Transferring and implementing processes, either from development, or from another manufacturing facility.
Partner with technical leadership and cross-functional partners such as Manufacturing, Quality, Engineering, Finance, and Facilities to implement appropriate written documentation.
Work with initiators to rewrite, clarify, or reconstruct controlled documents and investigations.
Developing specifications in the form of a URS for new equipment purchases.
Conduct MSA studies for products and new processes.
Responsibility as technical lead for projects (value stream and cross functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification, and operational handover as appropriate.
Observing the Quality Management Systems requirements on site at all times
Requirements:
Education:
Level 8 Degree in Mechanical Engineering or equivalent technical experience is required.
Experience:
Minimum 5 Years experience with at least 2 years' experience in a GxP manufacturing environment.
Proven Project Engineering skills through the delivery of business-critical projects or equivalent.
Skills:
Strong communication and influencing skills with both internal and external agents.
Capable of working as part of a multi-disciplined team in a dynamic and results motivated environment.
Demonstrable analytical & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment.
Six Sigma/lean expertise demonstrated in the manufacturing, process development and validation of new products is highly desired.
Work location:
Athlone, Ireland
Hybrid Eligible
The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice.
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
Diversity & Inclusion
( ) We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, gender, sexual orientation , age, civil status, disability, family status, or membership of the travelling community.
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