Project Manager

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

• Develop project timelines, resource allocation plans, and budgets, ensuring timely and on-budget delivery.

• Coordinate and oversee all stages of project execution from design, development, and validation through to FDA submission.

• Lead and manage complex projects related to the development, commissioning, process development and validation of aseptic pharmaceutical or medical device products.

• Ensure compliance with FDA and other regulatory bodies’ requirements, particularly in aseptic areas and sterile manufacturing processes.

• Prepare and review documentation for FDA submissions and other regulatory filings.

• Work closely with internal stakeholders (R&D, quality assurance, operations, regulatory affairs, etc.) to ensure cross-functional alignment and timely execution of project milestones.

• Manage risk assessments and mitigation strategies to address project challenges.

• Conduct periodic project reviews and provide status reports to senior management, highlighting key project milestones, risks, and issues.

Requirements

• 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.

• PMP certified preferable.

• 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.