Senior Process Engineer 7/18/2018
Maryland Heights, MO
JOB DESCRIPTIONAPPLY ABOUT CURIUM:
Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC. Curium is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.
Our diverse group of industry experts is unified under one strong and singular focus to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe. In fact, we have over 6,000 customers in over 70 countries world-wide.
At Curium, every single dose counts in helping doctors and patients diagnose and treat disease. That means every single employee counts toward meeting this unified objective to help each patient live Life Forward . We have an amazing team that lives by our core values every single day integrity, commitment and collaboration. Come grow with us!
SUMMARY OF POSITION:
Provides technical discipline and leadership required to maintain, plan and implement robust and capable processes. Identifies and implements improvements and new technologies to processes to increase productivity, improve quality and reduce costs. Is the leader of equipment troubleshooting efforts; coordinating other support groups to return equipment to service. Is the leader of product/process failure investigations; implementing corrective actions and preparing sound scientific reports. Authors and provides technical support for developing processes and equipment documents including URS, DOE and validation documents. Provides change control authority to ensure the validated status of equipment is maintained. Reviews, monitors and trends daily operating data as needed, issues reports and recommendations based on operating data. Technical requirements include a thorough and demonstrable knowledge of cGMP's and applicable Industry standards.
* Execution of method development, validation and transfers, including as well as compendial assessments and verifications including preparation of all supporting documentation (i.e. protocols and reports).
* Composing User Requirements Specifications (URS) for equipment and upgrades.
* Maintain control of area process changes and serve as the primary departmental owner of equipment management of change activities.
* Providing adequate and documented monitoring of the process through trending, run reports, and tracking Operational Equipment Efficiency (OEE). Use OEE to identify process improvements.
* Leading process troubleshooting efforts.
* Assist in the development and maintenance of process equipment, procedures, batch records, and training materials.
* Identifying capital needs for the process.
* Support departmental change initiatives for continual improvement, specifically around Operational Excellence, 6-Sigma and Lean Manufacturing applications. Primary departmental driver for cost reduction initiatives.
* Facilitate technical transfers with R&D.
* SME for the process.
* Provides annual capacity analysis.
* Provides technical expertise to project management teams during project lifecycles.
* Executes projects, including:
* Purchases of equipment (lab furniture, laboratory equipment, process research equipment, etc.)
* Composing associated CER and processing financial information.
* Capital funding for outside services as it relates to manufacturing (risk assessments, validation services, process engineering assistance).
* Bachelor level degree in Mechanical, Electrical or Chemical Engineering or equivalent work experience required. (Other engineering disciplines may be considered based on experience.)
* Minimum Five (5) years of experience working as an engineer in a FDA regulated facility.
* Minimum two years of Manufacturing Experience; preferable in the manufacture of finished pharmaceuticals.
* Verifiable knowledge of and experience in application of cGMP's, validation, quality systems, document control and the impact of regulatory considerations on engineering initiatives.
* Experience in applied knowledge of aseptic behaviors and techniques associated with pharmaceutical production preferred.
* Experience with aseptic manufacturing equipment (Depyrogenation Ovens, Isolators, Lyophilizers, Liquid Fillers, etc.) preferred.
* Proven experience in leading teams, groups or efforts relating to processes and equipment.
* Knowledge of Windows based software applications such as Word, Excel, and Outlook is necessary.
* Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
* Must be willing to wear a variety of personal protective equipment.
* Willingness to work in a team based environment.
* Close attention to detail required.
* May be required to sit or stand for long periods of time while performing duties.
* Must be able to work outside of regular work hours.
* Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
* Must possess good hand-eye coordination.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
EQUAL OPPORTUNITY EMPLOYER:
Curium is an EQUAL OPPORTUNITY EMPLOYER. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.