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Senior Pharmaceutical Project Manager

2 months ago


Melville, New York, United States Lloyd Staffing Full time
Job Summary

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.
Requirements
  • 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.