Parenteral Process Scientist or Engineer
Validation & Engineering Group
Parenteral Process Scientist or Engineer
Validation & Engineering Group
Life sciences validation and compliance consulting
Process (Product) Validation, Statistics, PI Vision (nice to have) or some automation knowledge, on the floor execution with formulation tanks.
Bachelor Degree in Science ol Engineering or any other related Science field. • Five (5) years of experience in pharmaceutical manufacturing processes, technologies and aseptic processing equipment for parenteral and biological dosage forms. • Three (3) years of experience in pharmaceutical technology transfer, process improvements, characterization and validations. • Proficient knowlege of biopharmaceutical formulation processes, parenteral filling and syringe filling processes. • Proficient knowledge of product and process development, manufacturing scale up, continuous process improvement and troubleshooting processes in conformance with departmental standards and in compliance with regulations. • Detailed understanding of how parenteral manufacturing process are controlled and validated. • 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 to technology transfer and scale-up activities. • Strong project management skills. • Proficient time management skills, planning and organization capabilities. • Proven ability to influence and work with people at different levels and departments. • Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups. • Proficient in Statistical Process Control, Process Capability and Risk Assessment/Management • Proven assessment, analytical and problem-solving skills. • Proficient presentation skills and Technical Writing/Oral communication skills (English/Spanish) • Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry.
Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.
Life sciences validation and compliance consulting
Validation & Engineering Group provides regulatory compliance and engineering consulting for life sciences clients in Puerto Rico and the USA, serving pharma, biotechnology, medical devices, and food sectors. It guides the full product lifecycle, performing commissioning and qualification, computer system, equipment, process, and cleaning validation, drafting quality systems, and ensuring regulatory compliance with FDA and European standards. The firm differentiates itself with hands-on engineering expertise combined with deep regulatory knowledge and broad geographic reach, now enhanced after joining Pinnaql Inc. through an acquisition by 3Boomerang Capital, with founders continuing as partners for continuity. Its goal is to help clients bring products to market faster and more reliably by sustaining GMP-compliant operations and ongoing lifecycle compliance.
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