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Under the supervision of the Manager, Mechanical Process Engineering; the Solution Engineer is responsible for developing and executing process improvements and for generating and completing other technical activities and documents (e.g. Process and Equipment Validation protocols, Engineering Reports, Engineering Changes, Designed Experiments, Failure Modes and Effects Analysis, Test Method Developments) to support the efficient manufacturing of Epocal’s products in a manner consistent with CGMP and the Epocal QMS.
What will you do?
Proactively identifies the need for process development and improvement initiatives and takes the lead on defining and implementing these initiatives. Improvements include more robust process control methodologies for existing processes. Where required, understands and uses appropriate statistical techniques to justify the efficacy and reliability of proposed improvements.
Understands the Epocal Quality Management System and be able to successfully operate within its constraints.
Establishes productive relationships with personnel from engineering, operations, quality assurance and other groups, including external contractors.
Takes the lead on drafting new utilities, facilities, equipment and/or process validation protocols or modifying existing ones according to required process or product changes. Use established relationships with other groups to gather the required information for the protocols.
Organizes and participates in required execution of validation protocols and drive the release of the corresponding report. Ensure that all groups affected by the execution are informed and are contributing appropriately.
Communicates with supervisor and others when issues are detected, and improvements required.
Participates in test method improvements, Root Cause Analysis, pFMEA’s and Quality initiatives
Note: Duties are not limited to those listed above. Additional duties may be assigned as required. However, reasonable accommodations will be made if all possible under business conditions.
What will you bring?
Ability to draft complex protocols related to Experimental Design and Process Validation.
Attention to detail while maintaining the ability to multi-task and manage project timelines is essential
Good communication and interpersonal skills
What will you need to succeed?
Undergraduate degree in Chemical or Mechanical Engineering is desired, but other relevant disciplines such as Biochemistry, Biomedical Engineering or Engineering Physics may be considered. M.Sc. would be considered an advantage, and/or an equivalent combination of education and technical experience acceptable to Epocal
Minimum of 3 years of related industrial experience
Experience with process development and validation in a regulated industry such as pharmaceuticals or medical devices, are both highly preferred
Experience with development of process control strategies is highly preferred
Experience with Risk Analysis and Root Cause Analysis tools is preferred
Demonstrated knowledge and skill in the use of statistical tools and application of statistical tools and application of statistical software programs (JMP, Minitab)
Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
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