Project Manager 2 - Vaccines Production

Hi , We have an urgent job opening with our Direct client. Please go through the job description and let me know the following information: -Interest and good fit for the position (Y/N): - Availability - Visa status: - Best Contact number: - Best hourly pay rate expectation: - Please attach updated resume in word format. Title : Project Manager 2 - Quality Engineering Location : Baltimore, Maryland, 21230 Duration : 12+ months Job Description: Provide person-in-plant support for the tech transfer and GMP production of COVID Vaccine Drug Substance at Company, Baltimore, MD. Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure Company products and processes comply with cGMP requirements. Following successful tech transfer, support day-to-day quality oversight for production activities in the manufacturing plant, including identification of risks, deviation and CPA management, change control, and batch documentation review Support regulatory submissions and inspection readiness activities Build relationships and influence external partners to continuously enhance quality culture and business excellence Apply cGMP regulations and other FDA and international requirements to all aspects of the position. Job Requirements (required) Bachelor's Degree with a concentration in engineering, science, or an equivalent technical discipline Minimum of 8 years working in an FDA regulated environment Experience with biologics manufacturing operations or quality assurance Experience in aseptic processing Detailed knowledge of cGMPs related to pharmaceutical production Strong interpersonal and written/oral communication skills Ability to quickly process complex information and make critical decisions with limited information required Advanced degrees are a plus and may reduce the experience required Job Requirements (preferred) Experience in vaccines production Proficient in applying process excellence tools and methodologies Experience working with external manufacturers Up to 100% domestic travel required Regards, Mary Celestina Technical Recruiter Email: US # +1