Parenteral Process Scientist: Validation & Scale-Up Expert

Validation & Engineering Group; Juncos (PR); On-site; USD 75,000 - 90,000; Full time

Job summary

A prominent services supplier in pharmaceuticals seeks a Parenteral Process Scientist or Engineer. The role involves managing projects, ensuring compliance with FDA regulations, and applying technical knowledge to process validation in manufacturing. Ideal candidates have a Bachelor’s degree and several years of experience in pharmaceutical technologies. This full-time role offers opportunities in a dynamic environment within a leading company in the industry.

Qualifications

• 5 years of experience in pharmaceutical manufacturing processes and aseptic processing equipment.
• 3 years of experience in pharmaceutical technology transfer and process improvements.
• Proficient knowledge of biopharmaceutical formulation processes.

Responsibilities

• Manage multiple projects with minimal supervision.
• Utilize technical principles in scale-up activities.
• Ensure compliance with FDA and cGMP regulations.

Skills

Process Validation

Statistical Process Control

Project Management

Problem-solving skills

Technical Writing/Oral communication skills (English/Spanish)

Education

Bachelor Degree in Science or Engineering

Job description

Parenteral Process Scientist or Engineer

• Full-time

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

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.

By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply