• Formulation process validation
• Filling process validation
• Aseptic Processing experience
• Recent hands on experience executing process validations
• For filling, significant experience from production or engineering assignments to have in-depth knowledge of vial and/or syringe filling equipment sufficient to identify process CPP’s and generate detailed validation protocol requirements and coordinate execution
• For formulation demonstrated experience with mixing, dispense and filtration process validation.
Experience: 5 to 7 years. Experience in, Process Validation (formulation, filling, visual inspection and/or lyophilization),Performance Qualification, E&L, CCIT and Part 4 compliance
Familiar with Extractables/Leachables.
Skills
Skills, MS Office 2010, E Doc, Pharmaceutical Validation, Bio Pharma Validation, Validation execution,
Technical writing abilities and good time management. Strong root cause analysis skills with cGMP experience. To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required.
Must be proficient in E Doc with a working knowledge of templates, workflows and approval process
Proficient in MS Word, Excel, Powerpoint and Outlook
Interact well with a diverse group of individuals
Self-motivated and willing to be proactive in resolving issues
Excellent Verbal and written communication skills. Ability to work in a team environment
Education
BS/MS in Engineering, Life Science or Physical Science
