Director, Compliance and Validation

Barry-Wehmiller•East Brunswick, NJ

11d

About The Position

Director of Compliance & Validation, Life Sciences Who You’ll Work With You will join our East Brunswick, New Jersey office which is one of our 45+ offices in the US, be part of a committed team of over 1,500 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. When you join Design Group as a Director of Compliance & Validation , you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy. 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. Advises management in developing processes, policies, and procedures. Leads and directs the work of other employees. Implements effective engineering methods and provides technical guidance and acts as a resource for engineers. Ensures components, materials, and tools are used to capacity. Other duties as assigned

Requirements

A minimum of ten years of experience with increasing responsibility in validation/quality service and project management of life sciences, biotech, or other FDA regulated projects
Project management experience involving scope, budget, schedule, quality, risk, and client management
Experience developing business and client relationships
The ability to read engineering documents and experience in proposal development
An understanding of good documentation practices, cGMP, and FDA validation methods and systems
A working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance, and the latest industry expectations for data integrity
Strong project management software and word processing skills, and solid technical writing skills
A passion for a career in the life science industry
Experience in mentorship, multi-discipline collaboration, and in a consulting and service environment
A willingness to travel for project requirements including project installation and start-up activities, client and company sponsored meetings, trainings, industry related seminars, forums, and conventions,
A bachelor of science in engineering or a related technical degree

Nice To Haves

Diverse experience leading CQV project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation (preferred)
A solid understanding of EPCMV, Quality by Design, and risk analysis methods including FMEA, HAZOP and Fault Tree Analysis (preferred)

Responsibilities

Lead a team of validation professionals and interface with clients
Provide subject matter expertise in the validation of a variety of utility, facility, and process equipment
Develop project scope statements, estimates, and proposals
Lead regional business development efforts and expand engagements with existing clients
Work on multiple projects simultaneously
Ensure project objectives are met
Make an impact day-to-day with your skills and expertise, strengthening relationships with our clients and teams
Advises management in developing processes, policies, and procedures.
Leads and directs the work of other employees.
Implements effective engineering methods and provides technical guidance and acts as a resource for engineers.
Ensures components, materials, and tools are used to capacity.
Other duties as assigned