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Sr. Project Engineer
Job Description
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.
- 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.
Job 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.
Meet Your Recruiter
Doug Berkowitz
I’m Doug Berkowitz and I joined the field of Executive Search nearly 30 years ago, specializing in these industries: Consumer Packaged Goods, Pharma, Cosmetics, Fashion, e-Commerce, Health and Beauty. I handle middle and senior management roles. I pride myself on building relationships and never giving up on even the most challenging talent search. I believe that when you do the right thing for clients and candidates - they always come back. It’s all about the relationship. I have built a great reputation in multiple industries and I continue to develop strong relationships with professionals across a broad array of disciplines.
My team has expanded our reach to cover the entire U.S. and we have continued to grow since our merger with Lloyd Staffing. (We were formerly APR Executive Search.) The future is very bright. If the pandemic taught me anything, it’s don’t sweat the small stuff. — Just work hard, play harder and enjoy life.
In my free time I love fitness, cooking, eating excellent food, drinking great tequila and traveling. I’m an avid sports fan and love just hanging with my friends and family.