The Manufacturing Technology Associate II core responsibilities include supporting the design of validation sampling/test plans, performing development studies, generating validation protocols, executing validation studies, resolving technical issues encountered during study execution, and preparing validation final reports for cleaning, sterilization, process, manufacturing/analytical equipment, and utility system qualifications. Projects are typically small or part of larger projects. Projects are assigned by management.
The Manufacturing Technology Associate II also supports technology transfer activities tracked in the site change control system, method validation/method transfer, filter validation, shipping qualification, and FAT/SAT/Commissioning activities. The individual may assist with validation master plans. The individual should possess strong technical skills and experience with biopharmaceutical unit operations and equipment.
The position may require off-shift and weekend work as well as infrequent travel.
Knowledge: Full use and application of principles, theories, concepts and techniques in a limited area or field.
Problem Solving: Develops solutions to problems within job scope where precedents exist. Depending upon ability, may determine individual approach to devising solutions to problems.
Discretion/Latitude: Works under general supervision to meet project goals. Work is reviewed for soundness of technical approach.
Impact: Recommendations consistently result in project advancement. Contributes to technology development or support programs. Effectively functions as a member of one or more project teams.
Interpersonal Communications: Primary interaction is within the organization. Has some internal customer or outside supplier contacts on routine matters. Has established working relationships and credibility with department members and others within the company.
Typical Education: B.S./B.A./M.S. in Engineering, Biological/Physical Sciences, or equivalent focus of study.
MedImmune - 18 months ago
MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...