Project Manager, Validation

BW Design Group; East Brunswick Township (NJ); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Professional development resources

Mentorship programs

Flexible working environment

Job summary

A leading engineering consultancy in East Brunswick Township is seeking a Sr. Validation Engineer with over 10 years of experience in validation of pharmaceutical processes and equipment. This role involves managing validation projects, developing FDA compliance documents, and serving as the primary engineering contact for clients. The ideal candidate has strong leadership, communication skills, and a relevant technical degree. Join a dynamic team that supports your growth within a flexible and rewarding environment.

Qualifications

• 10+ years of experience with validation in pharmaceutical or medical device industries.
• Experience in FAT, SAT, IQ, and OQ documentation.
• Excellent leadership and interpersonal skills.
• Strong computer skills and ability to travel.

Responsibilities

• Prepare and execute commissioning and qualification documents.
• Lead multiple validation projects simultaneously.
• Develop validation documents for pharmaceutical equipment.
• Serve as primary contact for pharmaceutical manufacturing clients.

Skills

Project management

Validation experience

Strong communication skills

Leadership

Education

Bachelor’s degree in Chemical Engineering

Biomedical Engineering or equivalent

Tools

FDA compliance documentation

Automated Systems

Job description

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

You’ll work individually and in teams to support capital projects and implement solutions for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals.

• Responsible for preparing, executing commissioning and qualification documents for a variety of utility, facility, and process equipment.
• Lead 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.
• Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering or equivalent technical degree.

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Sr. Validation Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.

Feel like you're on the path to becoming a Project Manager, Validation but you're not quite there yet? We'd love to connect with you to see if we can take you from where you are today and grow you into a Design Group Engineering Consultant.