Project Manager to lead and manage projects in the aseptic areas, particularly in the development, validation, and FDA submission processes for pharmaceutical and medical device products.
Responsibilities: ?
Lead and manage complex projects related to the development, validation, and commercialization of aseptic pharmaceutical or medical device products.
Coordinate and oversee all stages of project execution from design, development, and validation through to FDA submission.
Develop project timelines, resource allocation plans, and budgets, ensuring timely and on-budget delivery.
Prepare and review documentation for FDA submissions and other regulatory filings.
Manage risk assessments and mitigation strategies to address project challenges.
Requisitos:
Bachelor's degree in Engineering, Life Sciences, or a related field (Master's degree preferred).
8+ years of experience in project management in a regulated pharmaceutical, biotechnology, or medical device industry, with a focus on aseptic areas and FDA submissions.
Proven track record of leading projects through FDA submissions.
Strong knowledge of FDA regulations (CFR Part 210/211, 21 CFR Part 820), aseptic processing, validation protocols, and good manufacturing practices (GMP).
Experience with process validation, cleaning validation, and equipment qualification in aseptic manufacturing.
