Overview
On Site
Full Time
Skills
Quality Management
Professional Development
Communication
Project Management
Forecasting
Policies and Procedures
Writing
Change Management
Quality Assurance
Mechanical Engineering
Chemistry
Biochemistry
Good Manufacturing Practice
Documentation
Collaboration
GMP
Conflict Resolution
Problem Solving
Risk Assessment
Science
Manufacturing
English
Job Details
Responsibilities:
- Provide technical input to validation activities.
- Represent process validation during equipment installations.
- Support process validation Quality Systems.
- Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices.
- Participate in regulatory agency inspections for Process Validation.
- Serve as one of the main points of contact in communication to customers whose equipment and processes are being validate.
- Responsible for updating site Project Management and aiding in schedule and cost forecasting of validation activities.
- Complies with company, quality and safety standards, policies, and procedures.
- This position is responsible for writing, implementing, analyzing results and summarizing process validation activities in the areas of equipment installation, change management, and continuous lifecycle improvement.
- Will include developing and accessing following the Quality System elements for process Validation including CAPAs and deviations.
- This position will work closely with members of the Quality Assurance, Manufacturing, and Engineering teams to develop process validation studies and projects to enhance the manufacturing processes to compliantly achieve organizational goals.
- Bachelor's degree in chemical/Biochemical/Bioprocess/Industrial/Mechanical Engineering, Chemistry, Biochemistry, or related field with 3 or more years relevant experience.
- Experience authoring and completing validation studies.
- Understanding of for cGMP requirements validation documentation.
- Demonstrated ability to collaborate with multiple functions to implement validation activities and incorporate validation results into routine operational practices.
- Experience authoring and building process validation studies for commercial GMP manufacturing processes
- Experience troubleshooting/problem-solving and risk assessment/mitigation.
- Working knowledge of the science and technology for the major unit operations associated with manufacturing operation is considered a plus.
- Must be able to read, write and speak English.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.