Job Title
Quality Engineer Intern
Requisition
JR000014799 Quality Engineer Intern (Open)
Location
Raleigh, NC
Additional Locations
Job Description Summary
The Quality Engineer Intern would gain an understanding of day-to-day operation of a 24/7 Active Pharmaceutical Ingredient manufacturing facility, including the supporting Quality Control laboratory. The Quality Engineer Intern will support the Quality Control team and the Quality Systems team, gaining an understanding in analytical method validations and quality risk assessments for pharmaceutical manufacturing. Projects the intern will participate in or lead are as follows:
o Perform sample analysis and/or author protocols in conjunction with multiple analytical method verifications/validations.
o Write and execute experimental plans for solution stability studies, including statistical analysis of results.
o Develop a Risk Management system for documenting, storing, and logging risk assessments for various quality systems and legacy documents.
o Create risk assessments and templates. Aid in training others on how to compose risk assessments by creating best practices.
Job Description
Essential Functions
- Complete one or more special projects intended to be led by candidate and completed within the summer term.
- Practice basic lab-bench skills (pipettes, balances, titration, pH, etc.) as well as hands-on opportunities with instrumentation (FTIR, UV/Vis, Chromatography, etc.). Perform and/or coordinate qualitative tests and quantitative assays using techniques on equipment varying from standard analytical equipment to modern automated instrumentation.
- Work with various site departments (Quality, Manufacturing, Warehouse/Receiving, etc.) to document, create, and train others on risk assessments.
- Independently interpret and evaluate data in terms of accuracy and precision in relation to established expectations.
- Engage in safety discussions and follow laboratory and plant safety requirements.
- Engage with Quality Control and Quality Systems team members on group goals and delivers on individual responsibilities.
- Demonstrated ability to perform duties with a sense of urgency and delivers results in order of business impacting priorities.
Minimum Requirements
Education / Experience / Skills:
- College Degree BS/AS in Engineering, Chemistry or science-related field, either in-progress or completed.
- 0-1 years of experience in a science-related field. Knowledge of lab bench skills, lab instrumentation, or pharmaceutical manufacturing/testing is a plus.
Organizational Relationship/Scope:
- The intern will report to the Quality Control manager, but will be indirectly managed by Quality Systems Manager on certain projects. Other senior staff members may advise on a task-by-task basis. Frequent interaction with other site department personnel including site Quality Assurance, Manufacturing, Warehouse/Receiving and corporate partners.
Disclaimer:
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.
What We Do
At Mallinckrodt, we use strategic vision and employee-driven momentum to pursue a powerful mission: Listening for needs and delivering solutions.
As a leader in specialty pharmaceuticals, we develop, manufacture, market and distribute innovative treatments for underserved patient populations within neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. . Our expertise also extends into acute and critical care hospital products, as well as our broad portfolio of generic prescription medicines and active pharmaceutical ingredients.
Together, we’re helping shape the future of the specialty pharmaceuticals industry by leveraging the values our founders instilled over 155 years ago – quality, integrity and service.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Equal Opportunity Employer
Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.