MR01-011426 Process Development Scientist
Job Description
Job Description
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
SUMMARY
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.
FUNCTIONS
-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 OR
-Master's + 2 years of Scientific experience OR
-Bachelors + 4 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
-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
PREFERRED QUALIFICATIONS
1. Automated Visual Inspection (AVI) Expertise (Key Differentiator - Highly Desired)
• Direct experience with automated visual inspection systems, such as:
o Machine vision–based inspection platforms
o Camera systems, lighting optimization, optics
o Image acquisition and defect detection logic
• Knowledge of AVI system qualification and validation:
o IQ/OQ/PQ
o Performance qualification using defect kits
• Experience developing or supporting:
o Inspection recipes
o Defect libraries and defect standards
o Sensitivity and false reject optimization
• Familiarity with manual vs automated inspection correlation
2. Data, Statistics & Digital Skills (Preferred)
• Strong statistical background, including:
o Sampling plans (AQL, zero acceptance, etc.)
o Inspection capability studies
o Measurement system analysis (MSA)
• Experience with data analysis tools:
o JMP, Minitab, Python, or equivalent
• Comfort working with large inspection datasets to:
o Trend defect rates
o Support process improvements
o Drive inspection strategy decisions