Project Manager, Validation
BW Design Group · East Brunswick, NJ · 2 wk ago
Project ManagementFull-time
Who You’ll Work With
You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.
What You’ll Do
- Work individually and in teams to support capital projects and implement solutions for our clients.
- Help our clients make critical changes to improve their performance and realize their most important goals.
- Prepare, execute commissioning and qualification documents for a variety of utility, facility, and process equipment.
- Led and manage a diverse portfolio of validation projects simultaneously (equipment qualification, process validation, cleaning validation, system digitization, etc.).
- Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment.
- Serve as the primary on-site point of contact and local engineering leader for major pharmaceutical manufacturing clients.
- Build and maintain strong relationships with client stakeholders across operations, quality, regulatory, and executive levels.
- Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team.
What You’ll Bring
- Minimum 10+ years of demonstrated experience with validation of pharmaceutical or medical device processes and equipment.
- FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the Pharmaceutical Industry.
- Validation experience in the areas of automation, packaging, cleaning, Computer systems, utilities and/or facilities is desired.
- Excellent leadership skills including the ability to simultaneously organize, and successfully execute multiple project responsibilities.
- Candidates need to possess good communication and interpersonal skills and the ability to interact with all levels of management, clients, and vendors.
- Strong computer skills are also required.
- Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.
Qualifications
- Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering or equivalent technical degree.