Analytical Services Scientist

Requirements

• Bachelor degree in Science, Engineering, or Computer Science from an accredited institution
• At least five (5) years of laboratory experience or systems validation in an FDA regulated environment is required
• Excellent technical writing, experience on root cause analysis, and CAPA plan determination
• Broad knowledge of Laboratory instruments as HPLC, UPLC, Dionex, GC, Dissolution baths, TOC, FTIR, NIR, Automatic Titrator, UV Spectrophotometer, KF, among others
• Knowledge of Drug Enforcement Administration (DEA) regulations for controlled substances is required
• Fully Bilingual, excellent oral and written communication in both English/Spanish languages
• Skills in MS Office Suite applications of MS Project, Outlook, Word, and PowerPoint, and skilled at performing data evaluation, formulas, and metrics
• Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts, and theories in innovative ways
• Demonstrated analytical and problem-solving skills
• Proven ability to teach others and transfer knowledge to end users
• Able to work under pressure and self-starter
• Ability to work cross-functionally within an organization, being able to impact and influence other management teams that do not report to this position
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Regulatory (FDA) industry experience, familiarity with cGMPs, GAMP (Good automated manufacturing practice), Laboratory Equipment / Instrumentation C&Q practices (Commissioning & Qualification) and current to Pharmacopeias requirements, changes, and modifications
• Proven ability to learn new computer software/systems and laboratory instruments with minimum of instruction and general understanding of SLC (system life cycle) and CSV (computer validation system)
• Knowledge and experience with systems and validation processes
• Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines, effective project management skills

Nice to have:

• Master
• CSQE Certified Software Quality Engineer from ASQ (American Society for Quality)
• Chemical Licensee
• Knowledge on Laboratory Information Management Systems (LIMS Vantage or LIMS Lab Ware)
• Full knowledge on Chromatographic Data Management System (CDMS) as Empower

About the Company

Validation & Engineering Group (V&EG), a Pinnaql company, is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. The company believes in empowering employees to do their best work, fostering bold ideas and progress.