Validation Project Manager
PURPOSE OF THE POSITION: To provide broad based validation consulting services to regulated life sciences clients; such services will include project management as well as execution of project deliverables.
ESSENTIAL JOB FUNCTIONS / RESPONSIBILITIES: Responsible for the overall direction, coordination, implementation, execution, control and completion of specific validation projects ensuring consistency with company strategy, commitments and goals. Estimates project costs, develops proposals, and ensures adhering to project scope. Develops cost control programs and develops metrics to report project performance. Proficient in commonly-used concepts, practices, and procedures within the regulated life sciences industry. Prepares all protocols and reports for equipment, facility, utility, and cleaning validation work in pharmaceutical/medical device industry. Performs validation master planning and has a thorough understanding of the validation life cycle and possesses the ability to lead validation strategic planning. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Responsible for the quality review and approval of validation documents (including process, equipment, computer, and method) to ensure that the documents are accurate, complete, and meet internal and external regulatory requirements such as GMP, ISO, GAMP, ISPE.
MANAGERIAL RESPONSIBILITIES: Constantly monitors project performance and reports to senior leadership. Develops project schedules and project plans. Hires and negotiates compensation with employees and contractors. Manages resource allocation.
EDUCATIONAL REQUIREMENTS: Bachelor of Science in Engineering preferred, or a Bachelor of Science in a related life science field
EXPERIENCE REQUIREMENTS: 5+ years of experience in the field or in a related area.
REQUIRED SKILLS / QUALIFICATIONS: Strong written and oral communication skills are required. Excellent technical writing skill is required. Must be proficient in Microsoft Office products, including Microsoft Project (or equivalent). Must be proficient with GDP and cGMPS. Qualification in Project Management/Project Management Certification
PERSONAL TRAITS: Must be motivated, possess strong leadership skills, have the ability to work independently and/or function in a team environment.
PHYSICAL REQUIREMENTS: Able to lift up to 30 pounds and sit for long periods of time
TRAVEL REQUIREMENTS: Travel up to 100% may be required.