Parenteral Process Scientist or Engineer

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 or 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 knowledge 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 processes 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.