|Company Name:||System One|
|Job Location:||Elkton, VA|
|Job Posted Date:||20-04-2023|
System One is seeking a Technical Operations Engineer II in Elkton, VA. Please take a moment to read the job post below if you are interested:
Title:Technical Operations Engineer II
Location: Elkton, VA
Start date: ASAP
Our client is looking for the following:
- End to End raw material and single use component support; including material selection, qualification, material build into company systems, supplier complaint support, and continuous improvement.
- Creation, qualification, and commercial use implementation of new raw material and single use technology supply chains
- Extension of raw material supply chains and single use technology materials from other commercial and development products
- Qualification of single use technology for compatibility, biocompatibility, extractables and other process suitability characteristics
- Interaction with suppliers and using areas to manage design and suitability of single use technology
- Management of change elements supporting new and extended raw material supply chains and single use devices
- Ongoing interaction with local and extended network (US, EU) manufacturing, development organizations, communities of practice, and centers of excellence for the selection and deployment of single use technology.
- Design and execution of continuous improvement projects in support of these responsibilities, including procedure and form management
With the following credentials:
- A Bachelor’s Degree in Science, Engineering or equivalent discipline with 1-2 years’ experience in a cGMP environment (technical, and/or quality)
- Chemistry knowledge to differentiate between chemical substance properties, storage conditions and differences in quality grades
- Raw material and/or single use component qualification knowledge
- Knowledge of compendial differences and requirements for raw materials and single use components
- GMP compliant documentation practices and data integrity
- Experience with SAP® software (navigation and data review / extraction)
- Ability to clearly communicate requirements and expectations with stakeholders with varied technical and non-technical backgrounds (business, quality, engineering, manufacturing, supply chain, production systems and compliance frameworks)
- Understanding of supply chain assessments and evaluation processes
- Supplier relationship / point of contact experience
- Change management within a cGMP environment The successful candidate must have
- Materials knowledge in support of the position responsibilities (compatibility, extractables, general chemistry)
- Strong verbal and written communication skills, team skills, personal character, and ethics
- Strong problem-solving skills and a hands-on approach to problem solving.
- Enthusiasm, confidence, and initiative-taking ability needed for continuous learning and its applications.
- Strong desire to succeed and to help others to do the same.
- Experience with component and material builds, within an SAP® environment is preferred but not required
- Supplier relationship experience is preferred .
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Getting the Technical Operations Engineer II designation comes with some responsibilities. It would be a wise idea to take a few minutes to learn more about it so you can make an informed decision.
Applicants must meet the above-mentioned requirements in order to qualify for consideration to work as a Technical Operations Engineer II.
By clicking on the apply now button, you will be redirected to the official recruitment website where you can fill out your application.