Description
PHARMACEUTICAL VALIDATION SPECIALIST / VALIDATION ENGINEERBloomington, IN (Indiana)
PRIMARY FUNCTION:
- To participate in validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation.
ESSENTIAL JOB DUTIES / RESPONSIBILITIES:
- Manage multiple projects to provide documented validation of equipment, control systems, cGMP utilities and manufacturing processes
- Develop validation master plans according to client processing steps
- Review process flow diagrams and perform risk analysis
- Schedule and sequence validation deliverables
- Review of equipment submittals and design specifications
- Analyze data associated with validation protocols
- Develop and review functional requirements specifications as related to process equipment
- Develop and/or review user requirement specifications
- Develop and review facility impact and component criticality assessments
- Develop validation protocols and associated summary reports
- Review facility change logs and provide input on revalidation activities
- Serve as an interface to process development and tech transfer teams
- Conduct design qualification for relevant process equipment
- Develop and review validation requirements and design deliverables
- Ensure facility validation strategies and policies are followed
- Lead validation projects as needed
- Provide schedule integration for validation projects
MINIMUM WORK EXPERIENCE / EDUCATION REQUIREMENTS:
- Bachelors Degree in Life Sciences, Chemical Engineering or Mechanical Engineering or equivalent experience
- Sign company required confidentiality and non-compete agreement
- Minimum 4 years of validation or pharmaceutical process engineering experience preferred
- Excellent oral and written communication skills and computer literacy skills
- Ability to effectively communicate with co-workers as well as management
- Basic computer skills including Microsoft Office applications
- Perform basic math skills and applications including addition, subtraction, multiplication and division including the ability to understand decimals
- Ability to coordinate efforts of various departments and contractors
To find out more about Real please visit www.realstaffing.com