Project Manager (FDA-Experience)

EducationBachelor’s Degree in an Applied Science or equivalent education and work experience – engineering preferredTechnical Experience5 years of validation project managementOther ExperienceExcellent oral and written communication skillsAttention to DetailExcellent understanding of current Good Manufacturing PracticesExtensive expertise in pharmaceutical processing, process equipment and computer systemsExpertise in Equipment Validations, Cleaning Validation, Process Validation, and Computer Systems Validation.Ability to assist clients by attendance at meetings with regulatory and FDA personnel.Responsibilities·         Management of project controls including budgets, schedules, meetings, and status reporting, includes reports to Management.·         Management of several concurrent projects for multiple clients.·         Able to manage resources and implement related project tasks that are tailored to fit each individual project and client.·         Demonstrate excellent organization and management skills assuring efficient and timely completion of projects.·         Responsible for the close monitoring of project budgets and timelines ensuring effective flow of validation activities leading to successful FDA inspections.·         Working with clients and study directors to establish protocol templates, to evaluate project goals, and to resolve any deficiencies·         Writing of Validation Master Plans·         Writing and revising Standard Operating Procedures·         Maintaining client relations.·         Validation project management; protocol development, review, approval, and execution; change management·         Reviewing project documentation to ensure compliance with client expectations and company requirements·         Travel is required, up to 100% travel (5 days per week). Company DescriptionGreat Company culture

Salary : $45 - $50