Sr. Project Engineer - LLoyd Staffing
Port Washington, NY 11050
About the Job
Position Summary:
We are seeking a Senior Pharmaceutical Project Engineer to join our client's team. In this role, you will collaborate with various departments to oversee key engineering projects related to cGMP process equipment, ensuring specifications and quality standards are met. The ideal candidate will thrive in a fast-paced environment, manage multiple projects simultaneously, and demonstrate strong leadership capabilities when required.
We are seeking a Senior Pharmaceutical Project Engineer to join our client's team. In this role, you will collaborate with various departments to oversee key engineering projects related to cGMP process equipment, ensuring specifications and quality standards are met. The ideal candidate will thrive in a fast-paced environment, manage multiple projects simultaneously, and demonstrate strong leadership capabilities when required.
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.
- 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.
Source : LLoyd Staffing