Process Validation Specialist

Purpose: Process Validation Specialist - Technical Services (Sr. Technical Specialist)
Leads solid oral dosage form process validation projects including protocol generation, execution (e.g. granulation endpoints, particle size, densities, drying studies, compression profiles), and report writing. Requires fluid bed granulation experience. Works with multi-disciplinary teams, including clients, providing validation expertise during the development, scale-up, optimization, and technology transfer of solid oral dosage forms. Develops validation master plans, schedules, and manages resources. Calculates cleaning validation acceptance limits and reviews and approves cleaning validation protocols. Leads cross-functional teams to develop validation best practices and standards; prepares specifications, production records, protocols, reports, and documentation to support process validation and regulatory submissions; provides technical/production support; troubleshoots, conducts investigations; collects data, analyzes, and interprets results.

Candidates must possess a BS or MS in chemical engineering, mechanical engineering, pharmaceutical sciences, or related field along with 6+ years' relevant experience in process validations and supervising or coordinating personnel in validating solid dosage form processes. Technology transfer and experience with liquids and semi-solids is a plus.

Classification:
Contract-to-Hire

Compensation:
DOE Hour

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
GRANULATION, PROCESS VALIDATION, PROTOCOL GENERATION, SOLID ORAL DOSAGE, CHEMICAL ENGINEERINGContact Information
Contact:Bradford,David