MV02-121823 Process Development 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:

• Process Development Scientist

Description:

• To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.
• Conceives and designs, executes or evaluates, and interprets experimental strategies.
• Provides input to new processes to generate robust and reliable data.
• Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
• Designs, monitors or conducts experimental strategies with general guidance from supervisor.
• Provides data analysis and interpretation, and assesses impact of the data on the project.
• Keeps current in field of scientific expertise and areas relevant to their function.
• Monitors field of expertise, including literature and technology development, and communicates relevant observations.
• May introduce advanced scientific methods.
• Develops and implements new and novel protocols to address specific issues.
• May represent the department on project teams under supervision of a senior scientific staff member.
• May initiate productive collaborations within and outside of the department or company.
• Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
• Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
• Participates in external scientific community.
• May assume lead role in department-wide support efforts such as safety, recruiting and committees.
• May develop supervisory and mentoring skills.
• Develops and follows timelines for completing project teamwork.

Education:

• Doctorate degree or Master's degree and 5 years of Scientific experience or Bachelor's degree and 6 years of Scientific experience.

Competencies/Skills:

• Advanced scientific analysis and troubleshooting skills.
• Advanced laboratory work skills.
• Ability to motivate and/or supervise the activities of others.
• Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
• Must have demonstrated skills and competencies in the following areas: Verbal communication, Written communication including technical writing skills, negotiation and conflict resolution.
• Analytical problem solving
• Project management.
• Ability to be flexible and manage change.
• Computer literacy (Windows environment: Word, Excel, Power Point).
• Skills requiring the application of scientific theory.
• Creative skills in the design and performance of scientific experiments and interpretation of results.
• Strong knowledge of cGMP's.
• Fully bilingual (English/Spanish).

Preferred:

• Personnel with experience in the inspection/packaging area, incoming (primary containers) or QC (defects).
• Monitors field of expertise, including literature and technology development, and communicates relevant observations.
• Understands and interprets primary components specifications and methods.
• Demonstrates knowledge regarding metal, glass and polymer formation process and primary container components defects and classifications.
• Performs Primary Packaging Evaluations and Glass/Polymers Forensic Analysis.
• Introduces advanced scientific methods.
• Develops and implements new and novel protocols to address specific issues.
• Represent the department on project teams under supervision.
• Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
• Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
• Participates with the external scientific community.
• Assumes lead role in department-wide support efforts such as safety, OE and other committees.
• Develops and follows timelines for completing project teamwork.
• Knowledge in Material Sciences (glass/polymers)
• Knowledge of the practical application of engineering, sciences, and technology.