About this role

Assist the shift lead in a hands-on approach to overseeing production activities including, filling, sterilization, component and equipment prep, and compounding.
Completes quality systems activities including commitments, deviations, DCEs, and SOP revisions as necessary.
Responsible for meeting budget, quality, and production goals, setting standards, and making employment and staffing recommendations.
Interpret manufacturing policies, procedures, and programs.
Qualified to work in and operate equipment in the assigned area of responsibility (i.e., ability to be gown qualified).
Assist the shift lead (supervisor) and Group Leader in ensuring production lines run efficiently and in a high state of compliance.
Emphasize training and ensures training compliance.
Support and emphasize the Safety and Quality commitments of the department.
Analyze staffing needs.
Responsible for driving operational excellence projects.

Requires a B.S. in technical discipline with 0 to 3 years experience in manufacturing processes or 5 years experience in pharmaceutical injectables manufacturing as an alternative to a 4 year degree.
Sound knowledge and understanding of cGMPs.
Ability to manage multiple priorities and projects.
Must work well as a member of a team.
Good oral and written communication skills.

Manufacturing Specialist

Key skills