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Senior Pharmaceutical Project Manager
2 months ago
We are seeking a highly skilled Senior Pharmaceutical Project Engineer to join our client's team in Nassau County, NY. As a key member of the engineering team, you will be responsible for overseeing key projects related to cGMP process equipment, ensuring specifications and quality standards are met.
Key Responsibilities- Manage the scope, deliverables, schedule, budget, and quality of engineering projects involving cGMP process equipment.
- Lead the design, site acceptance, and installation of equipment and critical utilities.
- Oversee design consultants and ensure timely project delivery.
- Prepare and present project status reports.
- Develop drawings and documentation for ongoing projects.
- Support QA/validation processes through design documentation and protocol reviews.
- Recommend and implement corrective/preventive actions for existing equipment and processes.
- Design, install, and qualify critical equipment, utilities, and facilities such as WFI systems, clean steam, and aseptic processing.
- Evaluate, approve, and execute change controls and quality management system (QMS) documentation.
- Act as a subject matter expert during regulatory inspections.
- Provide technical support for manufacturing and maintenance activities.
- Ensure compliance with local, state, and federal regulations while maintaining a safe working environment.
- Bachelor's degree or relevant experience in pharmaceutical engineering (preferred).
- Formal project management training is a plus.
- 10+ years of pharmaceutical project experience, or an equivalent combination of education and experience.
- Proficient with project management tools and industry best practices.
- Strong data analysis and decision-making skills.
- Ability to work effectively in cross-functional teams and lead projects.
- Experience with quality systems and regulatory requirements (CFRs, GMP, FDA, OSHA).
- Capable of working independently with strong leadership abilities.
- Understanding of validation principles and applications for equipment and processes.
- Willingness to travel domestically and internationally as required.