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Validation Specialist III (Engineering)


Location: Swiftwater, Pennsylvania
Job Category:

Duties
________________________________________
The Validation Specialist will be responsible for generating development / validation protocols and reports, compiling data packs and analyzing data for adherence to established acceptance criteria. Typical processes being developed / validated include mixing, filling, formulation, visual inspection and lyophilization, . Studies supporting these processes include hold time, CCIT, stability, Part 4 compliance. Experience Requirements:
• 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/Leachable.

Skills
Skills, MS Office 365, Proficient in MS Word, Excel, Powerpoint 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 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

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

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