MV02-043024 Analytical Method Validation Scientist

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Analytical Method Validation Scientist

MAJOR DUTIES AND RESPONSIBILITIES:

1. Designs, executes and evaluates method development protocols to ascertain the required degree of validation for new and existing methods guaranteeing implementation of a feasible, efficient, rugged, and robust method.
2. Supports technical aspects of test method ruggedness and robustness processes.
3. Supports the Analytical Ruggedness Project Manager and Quality Control to gather information on investigations, troubleshooting, method deviations, method optimization, and method change control.
4. Coordinates projects to assure successful and timely execution, issuance and updating of detailed time and event schedules.
5. Leads analytical special projects to accomplish company goals and objectives on a timely and effective manner.
6. Support laboratory instrument qualification including knowledge in Maximo, Infinity.
7. Generate IOQ and PQ reports for the qualification of Analytical Instruments.
8. Provides timely and efficient technical reports to document all analytical improvement or investigation projects.
9. Evaluates and appraises method and instrument changes in regard t regulatory requirements. Keeps current with emerging technologies, new instrumentation, and regulatory expectations relative to the pharmaceutical/development laboratory operations.
10. Trains Technical Operations analysts to perform existing and/or new analytical methods and generate training.
11. Verifies consistency with other site procedures and/or specifications.

KNOWLEDGE / SKILL:

• BS Degree in Natural Science in Biochemistry or Chemistry.
• The experienced required based on Degree is:
  • BS Degree with five (5) years experience in pharmaceutical industry with at least two (2) years experience in method development/transfer of biomolecules.
  • Master Degree with at least (2) two years experience in pharmaceutical industry in method development/transfer of biomolecules.
• Technical knowledge of proteins handling and analysis with specific experience in biomolecules method optimization and troubleshooting.
• Broad experience with analytical instrumentation and techniques (e.g. HPLC, GC, UV, FTIR, MS, CE, SDS-PAGE, SEC, ELISA)
• Literacy of pharmaceutical industry analysis of Bulk Products and/or finished dosage forms.
• Computer literacy (Microsoft office, etc) and presentation skills (English/Spanish).
• Technical writing and oral communication skills (English/Spanish).
• Leadership skills, time management, planning and organization capabilities.
• Excellent interpersonal skills and the ability to interact with people at all levels.
• Project management skills
• Knowledge of Statistical Process Control, and Design of Experiments with demonstrated analytical and problem-solving skills.
• Willing to work irregular hours, rotative shifts, weekends and holidays, when necessary.