Director of Validation

Job description

Description

Director of Validation, Life Sciences

Who You’ll Work With

You will join 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 BW Design Group as a Director of 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 collaborate 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.

Lead a team of technical 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 local business development efforts and expand engagements with existing clients

Make an impact day-to-day with your skills and expertise, initiating and strengthening relationships with our clients and team

What You’ll Bring

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

Diverse experience leading 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)

The ability to read engineering documents

Experience in proposal development

A solid understanding of EPCMV, Quality by Design, and risk analysis methods including FMEA, HAZOP and Fault Tree Analysis (preferred)

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 bachelor of science in engineering, biology, chemistry or a related 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 Director of Compliance & Validation, 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 Director of Compliance & 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 Director.

#LI-EPS

Barry-Wehmiller is an equal opportunity employer.

M/F/D/V This organization uses E-Verify.Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

Company:

Design Group

Required Skill Profession

Engineers