Engineer I - Senior Engineer I; R&D - ReqCode 11-8142

Responsibilities:

ESSENTIAL JOB RESPONSIBILITIES:

This position encompasses the technologies, techniques and processes used in the manufacture of liquid, semi-solid and solid oral dosage forms using both pilot and commercial scale equipment with a strong emphasis on solid oral dosage forms. Responsibilities will include support of product site-transfers, scale-up, and validation batches.

* Typical activities include reviewing past batch data, planning and manufacturing technical transfer and scale up batches.* Managing projects, generating characterization protocols & reports, justifying manufacturing incidents & deviations, and preparation of FDA submission documents.* Provides technical assistance for projects as manufacture scale-up/characterization batches to confirm or establish critical operating parameters for site transfer projects and process validation campaigns.* Communicates with other departments including, but not limited to, Planning, Quality Assurance, Operations, Quality Control, Regulatory Affairs, and Validation & Commercial Technical Services.* Assists in maintaining regulatory compliance and a safe work environment within the function. Follows Teva's safety, health, and environmental policies and procedures.

TRAVEL REQUIREMENTS: Less than 25% Domestic and International

Qualifications:

EDUCATION REQUIREMENTS: BS, MS or PhD in an Engineering Discipline, Pharmacy, Physical Sciences or the equivalent with 2 to 7+ years (pending education level) experience in Process Engineering/Development or a related field within the pharmaceutical industry.

JOB QUALIFICATIONS (Training, skills, and experience):* BS,MS or PhD degree in engineering discipline or physical sciences* 2+ years of experience in pharmaceutical production/technical development * Must possess excellent research and problem solving capabilities * Experience with high-shear granulators, hot melt technology, fluid bed dryers, Wurster coaters, SpiraFlows, roller compactors, blenders, tablet presses, and tablet coaters* Experience with immediate release, extended release, and sublingual tablets* Must be capable of producing detailed-oriented documentation, understand and make generalized and specific conclusions from all collected data of the project(s), in a fast-paced, highly visible environment* Statistical knowledge desirable (e.g. Process Capability Analysis), JMP software* Excellent verbal, written, computer, organizational and project management skills, along with a high degree of professionalism* Working knowledge of cGMP and DEA requirements* Must be a team player and a self starter capable of organizing their varied projects within the group with minimal supervision