Responsibilities:



Formulation process development/validation



Mixing development/validation



Filling process development/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 (preferably with Swiftwater Lines 6, 7, 8 and/or 9)



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.



Requirements:



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/Leachable.



MS Office 365, Proficient in MS Word, Excel, Power point and Outlook



Electronic Documentation system (Geode preferred), 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 to gather all the necessary information required.



Must be proficient in Geode with a working knowledge of templates, review workflows and approval process.



Excellent Verbal and written communication skills. Ability to work in a team environment.



Ability to support development, clinical or validation activities on 2nd/3rd shift or weekends as needed.